Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

Conditions
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Cancer Survivor, Stage I Rectosigmoid Cancer, Stage II Rectosigmoid Cancer, Stage III Rectosigmoid Cancer

Intervention / Treatment
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* Other: Informational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Survey Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (personalized dietary intervention)<br>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. | Other: Informational Intervention<br>* Receive a workbook<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive personalized dietary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability assessed by semi-structured interview | Will be assessed through qualitative data analysis using conventional content analysis approach. | Up to 6 months | 
| Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool | Descriptive statistics will be summarized using validated scoring procedures. | Up to 6 months | 
| Feasibility assessed by patient enrollment | 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. | Up to 6 months | 
| Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer | Descriptive statistics will be summarized using validated scoring procedures. | Up to 6 months |