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

Phase 2

Completed

Conditions: Rectal Carcinoma
Rectosigmoid Carcinoma

Registration Number: NCT04205955

Lead Sponsor: SWOG Cancer Research Network

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVES:

I. To compare total bowel function score, as measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms.

EXPLORATORY OBJECTIVES:

I. To compare total bowel function score at 26 weeks post-randomization between the intervention and attention control arms.

II. To compare bowel function subscale scores (dietary, urgency, frequency), as measured by the BFI at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

III. To compare lower anterior resection syndrome (LARS) scores (for anastomosis participants only), quality of life, and dietary quality at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

IV. To compare motivation, self-efficacy, and positive/negative affect at both 18- and 26- weeks post-randomization between the intervention and attention control arms.

V. To assess study feasibility, adherence, retention, and acceptability at both 18 and 26 weeks post-randomization.

VI. To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study, patients are followed up at 26 weeks.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 95

Inclusion Criteria

PRIOR TO STEP 1 REGISTRATION:
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
Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration
Patient must have completed all baseline questionnaires within 5 days prior to registration
Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English
Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible
Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, are not eligible
PRIOR TO STEP 2 REGISTRATION:
Patient must meet all eligibility criteria for step 1
Patient must have successfully completed ("pass") the run-in period, as per email notification from the University of Arizona
Patient must be registered to step 2 no more than 40 days after step 1 registration. If day 40 falls on a weekend or holiday, the limit may be extended to the next working day
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bowel Function	At 18 weeks after randomization	Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (226): Banner University Medical Center - Tucson
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Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
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Tucson, Arizona, United States
UC Irvine Health Cancer Center-Newport
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Costa Mesa, California, United States
City of Hope Comprehensive Cancer Center
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Duarte, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Orange, California, United States
Presbyterian Intercommunity Hospital
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Whittier, California, United States
Beebe South Coastal Health Campus
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Frankford, Delaware, United States
Helen F Graham Cancer Center
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Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
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Newark, Delaware, United States
Beebe Health Campus
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Rehoboth Beach, Delaware, United States
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Banner University Medical Center - Tucson
🇺🇸Tucson, Arizona, United States