Survivor Choices for Eating and Drinking - Colorectal Cancer (SUCCEED)
Primary Purpose
Colon Cancer, Rectal Cancer, ColoRectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Website and text messages
Sponsored by
About this trial
This is an interventional other trial for Colon Cancer
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adherence
Frequency of logging on to website and responding to text messages
Secondary Outcome Measures
Dietary change assessed via diet records
Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol
Quality-of-life (EORTC C30)
Change in quality-of-life
Colorectal cancer-specific quality-of-life (EORTC C30 CR29)
Change in colorectal cancer-specific quality-of-life
Change in body mass index
Change in objectively measured BMI
Change in waist circumference
Change in objectively measured waist circumference
Change in fasting blood lipids
Change in fasting blood lipids
Change in fasting glucose
Change in fasting glucose
Full Information
NCT ID
NCT02965521
First Posted
November 14, 2016
Last Updated
December 19, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02965521
Brief Title
Survivor Choices for Eating and Drinking - Colorectal Cancer
Acronym
SUCCEED
Official Title
Survivor Choices for Eating and Drinking - Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
September 2, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, ColoRectal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Statistician who analyzes the data will be masked to intervention/control status.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Website and text messages
Intervention Description
Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.
Primary Outcome Measure Information:
Title
Adherence
Description
Frequency of logging on to website and responding to text messages
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Dietary change assessed via diet records
Description
Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol
Time Frame
12-weeks
Title
Quality-of-life (EORTC C30)
Description
Change in quality-of-life
Time Frame
12-weeks
Title
Colorectal cancer-specific quality-of-life (EORTC C30 CR29)
Description
Change in colorectal cancer-specific quality-of-life
Time Frame
12-weeks
Title
Change in body mass index
Description
Change in objectively measured BMI
Time Frame
12-weeks
Title
Change in waist circumference
Description
Change in objectively measured waist circumference
Time Frame
12-weeks
Title
Change in fasting blood lipids
Description
Change in fasting blood lipids
Time Frame
12-weeks
Title
Change in fasting glucose
Description
Change in fasting glucose
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31941707
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.
Results Reference
derived
Learn more about this trial
Survivor Choices for Eating and Drinking - Colorectal Cancer
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