Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Survivor
- Sponsor
- City of Hope Medical Center
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Acceptability assessed by semi-structured interview
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Acceptability assessed by semi-structured interview
Time Frame: Up to 6 months
Will be assessed through qualitative data analysis using conventional content analysis approach.
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
Time Frame: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Time Frame: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Feasibility assessed by patient enrollment
Time Frame: 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.