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Survivor Choices for Eating and Drinking - Colorectal Cancer

NCT ID: NCT02965521

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2018-11-20

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.

Detailed Description

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Conditions

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Colon Cancer Rectal Cancer ColoRectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Statistician who analyzes the data will be masked to intervention/control status.

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Website and text messages

Intervention Type BEHAVIORAL

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Website and text messages

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Van Blarigan, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36763183 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31941707 (View on PubMed)

Other Identifiers

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16-19417

Identifier Type: -

Identifier Source: org_study_id