Adenocarcinoma of the Rectum, Cancer of Rectum, Cancer of the Rectum, Neoplasm, Rectum, Rectal Cancer, Rectum Cancer, Rectum Neoplasms
Conditions
Brief summary
The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.
Interventions
RADIATIONRadiation
DRUGOxaliplatin
DRUGLeucovorin
DRUGFluorouracil
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound * Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a * ECOG performance status 0-2 * At least 18 years of age * Adequate bone marrow function defined as: * ANC \> 1,500 cells/mm3 * Hgb \> 8 g/dl * platelets \>100,000 cells/mm3 * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion criteria
* No clinically detectable (MR, endoscopy or DRE) tumor present * Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer. * Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible. * Currently receiving any investigational agents. * A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry. * Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 1 year | * Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Baseline | -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much). |
| Number of Any Grade 3 or Higher Toxicities | From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Number of Post Chemotherapy Grade 3 or Higher Toxicities | Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Quality of Anorectal Function as Measured by the FACT-C Questionnaire | Baseline | -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU * Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU |
|---|---|
| Age, Continuous | 56.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 8 / 20 |
Outcome results
Primary
Complete Response Rate
* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions
Time frame: 1 year
Population: 1 participant was not evaluable for this outcome measure as they were removed for an adverse event
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Complete Response Rate | 12 Participants |
Secondary
Number of Any Grade 3 or Higher Toxicities
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Pancreatitis | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Anemia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Febrile neutropenia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Cardiac arrest | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Myocardial infarction | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Ventricular fibrillation | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Abdominal pain | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Diarrhea | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Fever | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Cholectystitis | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Lung infection | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Fall | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Activated partial thromboplastin time prolonged | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Aspartate aminotransferase increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Cardiac troponin I increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Cardiac troponin T increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Lymphocyte count decreased | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Neutrophil count decreased | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | White blood cell decreased | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Dehydration | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hyperglycemia | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hypokalemia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hyponatremia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Generalized muscle weakness | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Peripheral sensory neuropathy | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Syncope | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Respiratory failure | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Aspiration | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Dyspnea | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hypoxia | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Cellulitis | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hypertension | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Hypotension | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Any Grade 3 or Higher Toxicities | Thromboembolic event | 1 Participants |
Secondary
Number of Post Chemotherapy Grade 3 or Higher Toxicities
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)
Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Anemia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Febrile neutropenia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Cardiac arrest | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Myocardial infarction | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Cardiac troponin T increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Ventricular fibrillation | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Abdominal pain | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Diarrhea | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Fever | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Cholecystitis | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Lung infection | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Activated partial thromboplastin time prolonged | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Aspartate aminotransferase increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Cardiac troponin I increased | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Lymphocyte count decreased | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Neutrophil count decreased | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | White blood cell count decreased | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Dehydration | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Hyperglycemia | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Hypokalemia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Hyponatremia | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Generalized muscle weakness | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Peripheral sensory neuropathy | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Syncope | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Respiratory failure | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Aspiration | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Dyspnea | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Hypoxia | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Cellulitis | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Hypotension | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Thromboembolic event | 1 Participants |
Secondary
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: 10-14 months after chemoradiation (approximately 16-20 months)
Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 14 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 15 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 10 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 10 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 15 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 6 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 9 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 9 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 6 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 12 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 15 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 17 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 4 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 7 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 8 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 7 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 4 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 15 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 3 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 10 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 15 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 12 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 15 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 10 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 2 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 3 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 6 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 9 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 14 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 9 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 13 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 4 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 5 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 15 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 15 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 0 Participants |
Secondary
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 17 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 10 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 12 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 17 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 19 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 9 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 8 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 11 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 19 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 6 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 14 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 19 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 19 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 9 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 9 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 8 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 7 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 8 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 8 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 20 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 9 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 13 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 19 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 18 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 2 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 19 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 13 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 6 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 6 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 11 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 18 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 12 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 15 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 19 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 11 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 12 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 4 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 20 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 20 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 0 Participants |
Secondary
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: Completion of chemoradiation (approximately 112 days)
Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 12 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 11 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 4 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 6 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 2 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 16 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 13 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 16 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 4 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 11 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 8 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 13 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 10 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 3 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 16 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 5 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 11 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 10 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 11 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 5 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 4 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 1 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 7 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 3 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 8 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 2 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 6 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 1=A Little Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 11 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 6 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 1 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 4 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 2 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 8 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 8 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 3 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 5 Participants |
| 2=Somewhat | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 8 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 7 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 6 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 5 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 1 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 7 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 3 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 3=Quite a Bit | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 5 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 15 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 6 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 10 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 17 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 14 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 14 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 4 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 1 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 3 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 8 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 14 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 8 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 4 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 16 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 7 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 6 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 9 Participants |
| 4=Very Much | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have accepted my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing hope in the fight against my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Because of my physical condition, I have trouble meeting the needs of my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am sleeping well | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with how I am coping with my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am enjoying the things I usually do for fun | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel sad | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with my sex life | 3 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have nausea | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am content with the quality of my life right now | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my partner (or the person who is my main support) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have swelling or cramps in my stomach area | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am satisfied with family communication about my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My family has accepted my illness | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am losing weight | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get support from my friends | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am embarrassed by my ostomy appliance | 18 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have control of my bowels | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I get emotional support from my family | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel close to my friends | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I can digest my food well | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am forced to spend time in bed | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a lack of energy | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have diarrhea (diarrhoea) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel ill | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am bothered by side effects of treatment | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have a good appetite | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I have pain | 1 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Caring for my ostomy appliance is difficult | 18 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | My work (include work at home) is fulfilling | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to work (include work at home) | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry that my condition will get worse | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I like the appearance of my body | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I am able to enjoy life | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I worry about dying | 0 Participants |
| Prefer Not to Answer/No Answer/No | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | I feel nervous | 0 Participants |
Secondary
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 9 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 0 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 5 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 5 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 4 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 0 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 3 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 11 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
Secondary
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: Completion of chemoradiation (approximately 112 days)
Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 1 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 4 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 10 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 6 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 4 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 1 Participants |
Secondary
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: 10-14 months after chemoradiation (approximately 16-20 months)
Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 6 Participants |
| Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 6 Participants |
| 1=A Little Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 7 Participants |
| 2=Somewhat | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 5 Participants |
| 3=Quite a Bit | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have control of my bowels | 2 Participants |
| 4=Very Much | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | I have diarrhea (diarrhoea) | 2 Participants |