Survivor Choices for Eating and Drinking - Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Survivor Choices for Eating and Drinking - Colorectal Cancer

Conditions
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Colon Cancer, Rectal Cancer, ColoRectal Cancer

Intervention / Treatment
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* Behavioral: Website and text messages


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Website and text messages<br>* Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.<br>|
| No Intervention: Control<br>Participants randomized to the control arm will receive print materials on diet for cancer survivors. After completion of their 12-week follow-up assessments, control participants will be given access to the web-based dietary intervention with text messaging for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Frequency of logging on to website and responding to text messages | 12-weeks | 

Secondary Outcome Measures

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