Survivor Choices for Eating and Drinking - Colorectal Cancer

NCT02965521 | Completed

• 2 other identifiers: 164511NCI-2017-01381
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer; ColoRectal Cancer

Outcome Measures

Primary Outcomes (1)

• Adherence

  Frequency of logging on to website and responding to text messages

  12-weeks

Secondary Outcomes (7)

• Dietary change assessed via diet records

  12-weeks

• Quality-of-life (EORTC C30)

  12-weeks

• Colorectal cancer-specific quality-of-life (EORTC C30 CR29)

  12-weeks

• Change in body mass index

  12-weeks

• Change in waist circumference

  12-weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Website and text messages BEHAVIORAL

Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (2)

• Wang L, Langlais C, Kenfield SA, Van Loon K, Laffan A, Atreya CE, Chan JM, Zhang L, Allen IE, Miaskowski C, Fukuoka Y, Meyerhardt JA, Venook AP, Van Blarigan EL. Quality of life among colorectal cancer survivors participating in a pilot randomized controlled trial of a web-based dietary intervention with text messages. Support Care Cancer. 2023 Feb 10;31(3):155. doi: 10.1007/s00520-023-07620-x.

  PMID: 36763183 DERIVED

• 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.

  PMID: 31941707 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Erin Van Blarigan, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician who analyzes the data will be masked to intervention/control status.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: April 10, 2017
• Primary Completion: September 2, 2018
• Study Completion: November 20, 2018
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)