NCT03063918

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Survivor
• Stage I Rectosigmoid Cancer
• Stage II Rectosigmoid Cancer
• Stage III Rectosigmoid Cancer

Interventions

Type	Name	Description
OTHER	Informational Intervention	Receive a workbook
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive personalized dietary intervention

Timeline

• Start date: 2017-04-28
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2017-02-24
• Last updated: 2024-02-22

Locations

2 sites across 1 country: United States