Rectal Carcinoma, Rectosigmoid Carcinoma
Conditions
Brief summary
This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.
Detailed description
PRIMARY OBJECTIVES: I. To compare total bowel function score, as measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms. EXPLORATORY OBJECTIVES: I. To compare total bowel function score at 26 weeks post-randomization between the intervention and attention control arms. II. To compare bowel function subscale scores (dietary, urgency, frequency), as measured by the BFI at both 18- and 26- weeks post-randomization between the intervention and attention control arms. III. To compare lower anterior resection syndrome (LARS) scores (for anastomosis participants only), quality of life, and dietary quality at both 18- and 26- weeks post-randomization between the intervention and attention control arms. IV. To compare motivation, self-efficacy, and positive/negative affect at both 18- and 26- weeks post-randomization between the intervention and attention control arms. V. To assess study feasibility, adherence, retention, and acceptability at both 18 and 26 weeks post-randomization. VI. To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6. ARM II: Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6. After completion of study, patients are followed up at 26 weeks.
Interventions
OTHERBest Practice
Receive healthy living education via phone call
DIETARY_SUPPLEMENTDietary Intervention
Receive diet modification coaching via phone call
OTHERMessage
Receive motivational messages via email and/or text message
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PRIOR TO STEP 1 REGISTRATION: * Patients must have prior history of rectosigmoid colon cancer or rectal cancer * Patients must have a post-surgical permanent ostomy or anastomosis * Patient's last date of treatment for rectal cancer (any surgery, chemotherapy, radiation therapy) must be at least 6 months prior to registration and not more than 24 months prior to registration * Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration * Patient must have completed all baseline questionnaires within 5 days prior to registration * Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English * Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible * Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, are not eligible * PRIOR TO STEP 2 REGISTRATION: * Patient must meet all eligibility criteria for step 1 * Patient must have successfully completed (pass) the run-in period, as per email notification from the University of Arizona * Patient must be registered to step 2 no more than 40 days after step 1 registration. If day 40 falls on a weekend or holiday, the limit may be extended to the next working day * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Function | At 18 weeks after randomization | Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Low Anterior Resection Syndrome (LARS) | Up to week 26 | LARS will be measured using the LARS Score. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Quality of Life-Assessment | Up to week 26 | Will be measured by the City of Hope-Quality of Life-Colorectal Cancer. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Dietary Quality | Up to week 26 | Will be based on the Healthy Eating Index 2015. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Motivation | Up to week 26 | Will be measured using a 10-item scale assessing motivation to change dietary behaviors in rectal cancer survivors. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Self-efficacy | Up to week 26 | Will be measured using the Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms - Short Form 4a. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Bowel Function | Up to week 26 | Will describe using dietary, urgency, and frequency scales. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
| Feasibility of the Intervention | Up to week 26 | Will be measured by the percentage of patients who successfully complete (pass) the run-in period, and randomized. Accrual rates and feasibility will be summarized. |
| Adherence to the Intervention | Up to week 18 | Will measure successful completion of intervention or attention control coaching calls. Adherence is defined as completing all five of sessions 1-5 and at least three of sessions 6-10 within 18 weeks after randomization. Study arm differences in adherence will be assessed by chi square tests. |
| Retention to the Intervention | Up to week 26 | Will be defined by completion of follow-up assessments in step 2, including those administered at follow-up site visits and the dietary recalls. Study arm differences in retention will be assessed by chi square tests. |
| Acceptability to the Intervention | Up to week 26 | Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test. |
| Positive and Negative Effects | Up to week 26 | Will be measured using the International Positive and Negative Affect Schedule Short Form. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate. |
Countries
Guam, United States
Participant flow
Pre-assignment details
95 participants were randomly assigned; 48 on the attention control arm and 47 on the intervention arm. Reasons for ineligibility include not completing run-in, withdraw of consent, and disease progression.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Diet Modification Coaching, Motivational Messages) Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Dietary Intervention: Receive diet modification coaching via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 47 |
| Arm II (Standard of Care, Motivational Messages) Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Best Practice: Receive healthy living education via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 46 |
| Total | 93 |
Baseline characteristics
| Characteristic | Arm I (Diet Modification Coaching, Motivational Messages) | Arm II (Standard of Care, Motivational Messages) | Total |
|---|---|---|---|
| Adjusted Diet because of Surgery/ostomy No | 12 Participants | 11 Participants | 23 Participants |
| Adjusted Diet because of Surgery/ostomy Yes | 35 Participants | 35 Participants | 70 Participants |
| Age, Continuous | 54.6 years | 56.9 years | 55.2 years |
| AJCC Clinical Stage at Diagnosis: M Stage M0 | 41 Participants | 42 Participants | 83 Participants |
| AJCC Clinical Stage at Diagnosis: M Stage M1 | 2 Participants | 0 Participants | 2 Participants |
| AJCC Clinical Stage at Diagnosis: M Stage Missing | 2 Participants | 1 Participants | 3 Participants |
| AJCC Clinical Stage at Diagnosis: M Stage MX | 2 Participants | 3 Participants | 5 Participants |
| AJCC Clinical Stage at Diagnosis: N Stage N0 | 18 Participants | 13 Participants | 31 Participants |
| AJCC Clinical Stage at Diagnosis: N Stage N1 | 14 Participants | 21 Participants | 35 Participants |
| AJCC Clinical Stage at Diagnosis: N Stage N2 | 12 Participants | 10 Participants | 22 Participants |
| AJCC Clinical Stage at Diagnosis: N Stage NX | 3 Participants | 2 Participants | 5 Participants |
| AJCC clinical stage at diagnosis: T Stage T1 | 4 Participants | 3 Participants | 7 Participants |
| AJCC clinical stage at diagnosis: T Stage T2 | 9 Participants | 6 Participants | 15 Participants |
| AJCC clinical stage at diagnosis: T Stage T3 | 33 Participants | 31 Participants | 64 Participants |
| AJCC clinical stage at diagnosis: T Stage T4 | 1 Participants | 5 Participants | 6 Participants |
| AJCC clinical stage at diagnosis: T Stage TX | 0 Participants | 1 Participants | 1 Participants |
| Any Change in Marital Status Since Diagnosis No | 46 Participants | 41 Participants | 87 Participants |
| Any Change in Marital Status Since Diagnosis Yes | 1 Participants | 5 Participants | 6 Participants |
| Body Mass Index (BMI) 18.5-<25 kg/m^2 (Normal weight) | 13 Participants | 12 Participants | 25 Participants |
| Body Mass Index (BMI) <18.5 kg/m^2 (Underweight) | 2 Participants | 0 Participants | 2 Participants |
| Body Mass Index (BMI) 25-<30 kg/m^2 (Overweight) | 16 Participants | 18 Participants | 34 Participants |
| Body Mass Index (BMI) >=30 kg/m^2 (Obese) | 16 Participants | 16 Participants | 32 Participants |
| Body Mass Index (BMI) | 27.3 kg/m^2 | 27.6 kg/m^2 | 27.3 kg/m^2 |
| Current Marital Status Divorced | 7 Participants | 6 Participants | 13 Participants |
| Current Marital Status Married or partnered | 34 Participants | 31 Participants | 65 Participants |
| Current Marital Status Single | 5 Participants | 7 Participants | 12 Participants |
| Current Marital Status Widowed | 1 Participants | 2 Participants | 3 Participants |
| Current Medication: Antibiotics No | 47 Participants | 44 Participants | 91 Participants |
| Current Medication: Antibiotics Yes | 0 Participants | 2 Participants | 2 Participants |
| Current Medication: Antidiarrheal Medications No | 32 Participants | 33 Participants | 65 Participants |
| Current Medication: Antidiarrheal Medications Yes | 15 Participants | 13 Participants | 28 Participants |
| Current Medication: Medication for Constipation No | 36 Participants | 36 Participants | 72 Participants |
| Current Medication: Medication for Constipation Yes | 11 Participants | 10 Participants | 21 Participants |
| Current Medication: Probiotics No | 36 Participants | 39 Participants | 75 Participants |
| Current Medication: Probiotics Yes | 11 Participants | 7 Participants | 18 Participants |
| Ethnicity Hispanic | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity Non-Hispanic | 42 Participants | 40 Participants | 82 Participants |
| Ethnicity Unknown | 2 Participants | 2 Participants | 4 Participants |
| Highest Level of Education Any college | 23 Participants | 24 Participants | 47 Participants |
| Highest Level of Education Any graduate school | 15 Participants | 12 Participants | 27 Participants |
| Highest Level of Education Completed high school/GED/vocational/secretarial/business | 7 Participants | 10 Participants | 17 Participants |
| Highest Level of Education Did not complete high school | 2 Participants | 0 Participants | 2 Participants |
| LAR Syndrome (LARS) Burden Major LARS | 35 Participants | 31 Participants | 66 Participants |
| LAR Syndrome (LARS) Burden Minor LARS | 6 Participants | 6 Participants | 12 Participants |
| LAR Syndrome (LARS) Burden Not applicable, ostomy | 6 Participants | 9 Participants | 15 Participants |
| Prior Surgery: Anastomosis No | 23 Participants | 30 Participants | 53 Participants |
| Prior Surgery: Anastomosis Yes | 24 Participants | 16 Participants | 40 Participants |
| Prior Surgery: Ostomy No | 41 Participants | 37 Participants | 78 Participants |
| Prior Surgery: Ostomy Yes | 6 Participants | 9 Participants | 15 Participants |
| Prior Surgery: Temporary Ostomy and Re-anastomosis No | 30 Participants | 25 Participants | 55 Participants |
| Prior Surgery: Temporary Ostomy and Re-anastomosis Yes | 17 Participants | 21 Participants | 38 Participants |
| Prior Treatment: Chemotherapy No | 6 Participants | 4 Participants | 10 Participants |
| Prior Treatment: Chemotherapy Yes | 41 Participants | 42 Participants | 83 Participants |
| Prior Treatment: Radiation Therapy No | 14 Participants | 8 Participants | 22 Participants |
| Prior Treatment: Radiation Therapy Yes | 33 Participants | 38 Participants | 71 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 39 Participants | 77 Participants |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
| Smoking Status Current | 1 Participants | 1 Participants | 2 Participants |
| Smoking Status Former | 9 Participants | 15 Participants | 24 Participants |
| Smoking Status Never | 35 Participants | 28 Participants | 63 Participants |
| Smoking Status Unknown | 2 Participants | 2 Participants | 4 Participants |
| Time Since Diagnosis | 23.6 months | 22.3 months | 23.3 months |
| Time Since Surgery | 15.9 months | 13.6 months | 14.0 months |
| Time to Comfort with Diet after your Surgery/ostomy 1 to 12 months | 15 Participants | 12 Participants | 27 Participants |
| Time to Comfort with Diet after your Surgery/ostomy I am still not comfortable | 22 Participants | 25 Participants | 47 Participants |
| Time to Comfort with Diet after your Surgery/ostomy Less than 1 month | 6 Participants | 6 Participants | 12 Participants |
| Time to Comfort with Diet after your Surgery/ostomy More than 12 months | 3 Participants | 3 Participants | 6 Participants |
| Time to Comfort with Diet after your Surgery/ostomy Not Answered | 1 Participants | 0 Participants | 1 Participants |
| Type of Cancer Other | 0 Participants | 1 Participants | 1 Participants |
| Type of Cancer Rectal | 39 Participants | 38 Participants | 77 Participants |
| Type of Cancer Rectosigmoid colon | 8 Participants | 7 Participants | 15 Participants |
| Type of Low Anterior Resection Surgery Abdominoperineal resection | 5 Participants | 10 Participants | 15 Participants |
| Type of Low Anterior Resection Surgery Low anterior resection | 42 Participants | 34 Participants | 76 Participants |
| Type of Low Anterior Resection Surgery Sigmoid colectomy | 0 Participants | 2 Participants | 2 Participants |
| Used Alternative Therapies for Bowel Issues in Past 5 Months No | 42 Participants | 42 Participants | 84 Participants |
| Used Alternative Therapies for Bowel Issues in Past 5 Months Yes | 5 Participants | 4 Participants | 9 Participants |
| Zubrod Performance Status 0 | 37 Participants | 31 Participants | 68 Participants |
| Zubrod Performance Status 1 | 8 Participants | 14 Participants | 22 Participants |
| Zubrod Performance Status 2 | 1 Participants | 0 Participants | 1 Participants |
| Zubrod Performance Status Missing | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Bowel Function
Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.
Time frame: At 18 weeks after randomization
Population: 95 total participants were randomly assigned; 47 on the intervention arm and 46 on the attention control arm. 3 patients were deemed ineligible for missing assessments and for other ineligibility criteria. This leaves 46 participants on the intervention arm and 44 on the attention control arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Diet Modification Coaching, Motivational Messages) | Bowel Function | 30.8 MSK-BFI score on a scale (range 18-90) |
| Arm II (Standard of Care, Motivational Messages) | Bowel Function | 29.5 MSK-BFI score on a scale (range 18-90) |
Other Pre-specified
Acceptability to the Intervention
Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test.
Time frame: Up to week 26
Other Pre-specified
Adherence to the Intervention
Will measure successful completion of intervention or attention control coaching calls. Adherence is defined as completing all five of sessions 1-5 and at least three of sessions 6-10 within 18 weeks after randomization. Study arm differences in adherence will be assessed by chi square tests.
Time frame: Up to week 18
Other Pre-specified
Bowel Function
Will describe using dietary, urgency, and frequency scales. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Dietary Quality
Will be based on the Healthy Eating Index 2015. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Feasibility of the Intervention
Will be measured by the percentage of patients who successfully complete (pass) the run-in period, and randomized. Accrual rates and feasibility will be summarized.
Time frame: Up to week 26
Other Pre-specified
Low Anterior Resection Syndrome (LARS)
LARS will be measured using the LARS Score. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Motivation
Will be measured using a 10-item scale assessing motivation to change dietary behaviors in rectal cancer survivors. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Positive and Negative Effects
Will be measured using the International Positive and Negative Affect Schedule Short Form. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Quality of Life-Assessment
Will be measured by the City of Hope-Quality of Life-Colorectal Cancer. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26
Other Pre-specified
Retention to the Intervention
Will be defined by completion of follow-up assessments in step 2, including those administered at follow-up site visits and the dietary recalls. Study arm differences in retention will be assessed by chi square tests.
Time frame: Up to week 26
Other Pre-specified
Self-efficacy
Will be measured using the Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms - Short Form 4a. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Time frame: Up to week 26