Survivor Choices for Eating and Drinking - Colorectal Cancer

Not Applicable

Completed

• Conditions: Rectal Cancer; ColoRectal Cancer; Colon Cancer
• Interventions: Behavioral: Website and text messages

• Registration Number: NCT02965521
• Lead Sponsor: University of California, San Francisco

Brief Summary

Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal cancer increases risk of disease recurrence and death. High intake of red and processed meat, dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'. This study aims to translate the epidemiologic findings into a patient-centered, web-based dietary intervention with text messaging to inform and modify users' dietary choices. The investigators' specific aims are to: 1) Develop a web-based dietary intervention with text messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized controlled trial to determine the acceptability and feasibility of the dietary intervention among 50 colorectal cancer survivors. All participants will receive standard of care print materials regarding diet following a colorectal cancer diagnosis. Participants in the intervention group will also receive access to a web-based dietary intervention with text messaging for 12 weeks. This study will generate preliminary data on the effect of the intervention on dietary choices among colorectal cancer survivors for future studies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Study Start: 2017-04-10
• Primary Completion: 2018-09-02
• Study Completion: 2018-11-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosed with colon or rectal adenocarcinoma
• completed standard cytotoxic chemotherapy prior to enrollment, if medically indicated
• considered disease-free or have stable disease at baseline
• able to speak and read English
• access to a mobile phone with Internet and text messaging capabilities
• able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the Internet

Read More

Exclusion Criteria

Individuals who are already meeting four or more of the six target dietary behaviors will be excluded:

• ≥5 servings/day of fruits & vegetables
• ≥3 servings/day of whole grains
• ≥2 servings/week of fish
• no processed meat
• no sugar-sweetened beverages
• ≤1 alcoholic drink/d for women and ≤2 alcoholic drinks/d for men.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Website and text messages	Participants will be given print material on diet for cancer survivors and access to a web-based dietary intervention with text messaging for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Adherence	12-weeks	Frequency of logging on to website and responding to text messages

Secondary Outcome Measures

Name	Time	Method
Dietary change assessed via diet records	12-weeks	Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol
Quality-of-life (EORTC C30)	12-weeks	Change in quality-of-life
Colorectal cancer-specific quality-of-life (EORTC C30 CR29)	12-weeks	Change in colorectal cancer-specific quality-of-life
Change in body mass index	12-weeks	Change in objectively measured BMI
Change in fasting blood lipids	12-weeks	Change in fasting blood lipids
Change in fasting glucose	12-weeks	Change in fasting glucose
Change in waist circumference	12-weeks	Change in objectively measured waist circumference

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States