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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02965521
Other study ID # 16-19417
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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