Survivor Choices for Eating and Drinking - Colorectal Cancer

ColoRectal Cancer Clinical Trial

— SUCCEED  

Official title:

Survivor Choices for Eating and Drinking - Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965521
• Other study ID #: 16-19417
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: November 20, 2018

Study information

• Verified date: December 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 20, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• ColoRectal Cancer
• Colorectal Neoplasms
• Rectal Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Frequency of logging on to website and responding to text messages	12-weeks
Secondary	Dietary change assessed via diet records	Change in consuming vegetables, whole grains, fish, processed meat, sugar-sweetened beverages, and alcohol	12-weeks
Secondary	Quality-of-life (EORTC C30)	Change in quality-of-life	12-weeks
Secondary	Colorectal cancer-specific quality-of-life (EORTC C30 CR29)	Change in colorectal cancer-specific quality-of-life	12-weeks
Secondary	Change in body mass index	Change in objectively measured BMI	12-weeks
Secondary	Change in waist circumference	Change in objectively measured waist circumference	12-weeks
Secondary	Change in fasting blood lipids	Change in fasting blood lipids	12-weeks
Secondary	Change in fasting glucose	Change in fasting glucose	12-weeks