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Trial record 22 of 580 for:    colon cancer | ( Map: California, United States )

Survivor Choices for Eating and Drinking - Colorectal Cancer (SUCCEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02965521
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 14, 2016
First Posted Date  ICMJE November 16, 2016
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
Adherence [ Time Frame: 12-weeks ]
Frequency of logging on to website and responding to text messages
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
Adherence (e.g., frequency of logging on to website) [ Time Frame: 12-weeks ]
Change History Complete list of historical versions of study NCT02965521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • Dietary change assessed via diet records [ Time Frame: 12-weeks ]
    Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol
  • Quality-of-life (EORTC C30) [ Time Frame: 12-weeks ]
    Change in quality-of-life
  • Colorectal cancer-specific quality-of-life (EORTC C30 CR29) [ Time Frame: 12-weeks ]
    Change in colorectal cancer-specific quality-of-life
  • Change in body mass index [ Time Frame: 12-weeks ]
    Change in objectively measured BMI
  • Change in waist circumference [ Time Frame: 12-weeks ]
    Change in objectively measured waist circumference
  • Change in fasting blood lipids [ Time Frame: 12-weeks ]
    Change in fasting blood lipids
  • Change in fasting glucose [ Time Frame: 12-weeks ]
    Change in fasting glucose
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • Dietary change assessed via diet records [ Time Frame: 12-weeks ]
  • Quality-of-life (EORTC C30) [ Time Frame: 12-weeks ]
  • Colorectal cancer-specific quality-of-life (EORTC C30 CR29) [ Time Frame: 12-weeks ]
  • Change in body mass index [ Time Frame: 12-weeks ]
  • Change in waist circumference [ Time Frame: 12-weeks ]
  • Change in fasting blood lipids [ Time Frame: 12-weeks ]
  • Change in fasting glucose [ Time Frame: 12-weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survivor Choices for Eating and Drinking - Colorectal Cancer
Official Title  ICMJE Survivor Choices for Eating and Drinking - Colorectal Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
Statistician who analyzes the data will be masked to intervention/control status.
Primary Purpose: Other
Condition  ICMJE
  • Colon Cancer
  • Rectal Cancer
  • ColoRectal Cancer
Intervention  ICMJE Behavioral: Website and text messages
Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Website and text messages
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2018
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965521
Other Study ID Numbers  ICMJE 16-19417
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin Van Blarigan, ScD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP