Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

Recruiting in Palo Alto (17 mi)

+228 other locations

Overseen byVirginia Sun

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Virginia Sun

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

Inclusion Criteria

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

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Treatment Details

Interventions

Dietary Intervention (Dietary Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (diet modification coaching, motivational messages)Experimental Treatment4 Interventions

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.

Group II: Arm II (standard of care, motivational messages)Active Control4 Interventions

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.