Clinical trial NCT02965521: Survivor Choices for Eating and Drinking - Colorectal Cancer
Official title: Survivor Choices for Eating and Drinking - Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
ColoRectal Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: 12-weeks
Secondary outcomes:
measure: Dietary change assessed via diet records
timeFrame: 12-weeks
measure: Quality-of-life (EORTC C30)
timeFrame: 12-weeks
measure: Colorectal cancer-specific quality-of-life (EORTC C30 CR29)
timeFrame: 12-weeks
measure: Change in body mass index
timeFrame: 12-weeks
measure: Change in waist circumference
timeFrame: 12-weeks
measure: Change in fasting blood lipids
timeFrame: 12-weeks
measure: Change in fasting glucose
timeFrame: 12-weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Erin Van Blarigan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Blarigan EL, Kenfield SA, Chan JM, Van Loon K, Paciorek A, Zhang L, Chan H, Savoie MB, Bocobo AG, Liu VN, Wong LX, Laffan A, Atreya CE, Miaskowski C, Fukuoka Y, Meyerhardt JA, Venook AP. Feasibility and Acceptability of a Web-Based Dietary Intervention with Text Messages for Colorectal Cancer: A Randomized Pilot Trial. Cancer Epidemiol Biomarkers Prev. 2020 Apr;29(4):752-760. doi: 10.1158/1055-9965.EPI-19-0840. Epub 2020 Jan 15.