Cancer Survivor, Stage III Rectosigmoid Cancer, Stage II Rectosigmoid Cancer, Stage I Rectosigmoid Cancer
Conditions
Brief summary
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
Detailed description
PRIMARY OBJECTIVES: I. Administer and determine the feasibility of the personalized dietary intervention. II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors. III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery. OUTLINE: At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content. After completion of study, patients are followed up for 6 months.
Interventions
OTHERInformational Intervention
Receive a workbook
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive personalized dietary intervention
Sponsors
National Cancer Institute (NCI)
Hope Foundation
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum * 6 months post-treatment completion * Have a permanent ostomy or anastomosis * English-speaking * All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion criteria
* Patients with stage IV disease will be excluded from the study * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability assessed by semi-structured interview | Up to 6 months | Will be assessed through qualitative data analysis using conventional content analysis approach. |
| Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool | Up to 6 months | Descriptive statistics will be summarized using validated scoring procedures. |
| Feasibility assessed by patient enrollment | Up to 6 months | Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete \>= 80% of the study. |
| Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer | Up to 6 months | Descriptive statistics will be summarized using validated scoring procedures. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Scores from the Decisional Conflict Scale | Up to 6 months | Descriptive statistics will be summarized. This analysis is exploratory only. Will use the findings to support future research related to treatment-decision making in rectal cancer. |
Countries
United States
Outcome results
None listed