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Trial record 22 of 584 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

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer ColoRectal Cancer Behavioral: Website and text messages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Official Title: Survivor Choices for Eating and Drinking - Colorectal Cancer
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : September 2, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Website and text messages
Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.

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.



Primary Outcome Measures :
  1. Adherence [ Time Frame: 12-weeks ]
    Frequency of logging on to website and responding to text messages


Secondary Outcome Measures :
  1. Dietary change assessed via diet records [ Time Frame: 12-weeks ]
    Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol

  2. Quality-of-life (EORTC C30) [ Time Frame: 12-weeks ]
    Change in quality-of-life

  3. Colorectal cancer-specific quality-of-life (EORTC C30 CR29) [ Time Frame: 12-weeks ]
    Change in colorectal cancer-specific quality-of-life

  4. Change in body mass index [ Time Frame: 12-weeks ]
    Change in objectively measured BMI

  5. Change in waist circumference [ Time Frame: 12-weeks ]
    Change in objectively measured waist circumference

  6. Change in fasting blood lipids [ Time Frame: 12-weeks ]
    Change in fasting blood lipids

  7. Change in fasting glucose [ Time Frame: 12-weeks ]
    Change in fasting glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965521


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Erin Van Blarigan, ScD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02965521     History of Changes
Other Study ID Numbers: 16-19417
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases