Clinical trial NCT04188002: A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
Official title: A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Physical Activity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2019-12-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single institution, randomized clinical trial designed to evaluate a four week web-based tailored health behavior intervention in breast and colon cancer survivors.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group. Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group. Both groups will fill out baseline surveys. The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online. The intervention newsletters focus on increasing physical activity and healthy diets. The control group will receive 4 newsletters in the same time frame as the intervention. The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g. getting back to work after treatment, managing finances) but will not focus on physical activity or diet. All contact with participants will take place online (i.e. surveys and newsletter delivery) from the study web site.

Detailed description: This study is adapted from the WATCH (Wellness for African Americans Through Churches) Project. WATCH was a randomized trial among 587 African American members of 12 rural North Carolina churches that demonstrated the effectiveness of a mailed tailored print and video intervention consisting of four individually tailored newsletters and targeted videos to improve diet and physical activity behaviors: there were significant improvements in fruit and vegetable consumption (0.6 servings) and recreational physical activity (2.5 MET-hours per week), and a non-significant decrease in fat intake in the intervention churches. The overall goal of this application is to conduct a study (called "eWellness") to investigate whether the WATCH tailored print messages and videos can be effectively and efficiently disseminated to a different population (breast and colon cancer survivors) and using a different delivery channel (electronic technology via the internet and world wide web.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* primary language is English
* histologically confirmed stage 1-111A invasive breast cancer or stage 1-3 colorectal cancer
* between at least 6 months to 5 years since completion of all primary cancer treatments (e.g. surgery, radiation, chemotherapy with the exception of women on adjuvant Herceptin therapy)
* have access to the internet; have an email and/or cell phone (to accept text message reminders from the study).

Exclusion criteria:

Include women that may be pregnant and anyone that is/has:

* A history of another cancer (exception for non-melanoma skin cancers)
* Self-reported comorbidities that would preclude engaging in physical activity safely (e.g. functional limitations or symptomatic cardiovascular or pulmonary disease)
* Plans or scheduled for major surgery (including breast reconstruction) during the intervention time frame
* Any psychiatric illness that would make it difficult to participate in the study

Primary outcomes:
measure: Mean Fruit and Vegetable Score
timeFrame: Month 6
measure: Summary Fruit and Vegetable Score
timeFrame: Month 6
measure: Metabolic Equivalent Task Hours (METs) for Physical Activity
timeFrame: Month 6
Secondary outcomes:
measure: Recruitment rate
timeFrame: Month 6
measure: Percentage of Participants Completing the Intervention and Follow-Up Assessments
timeFrame: Month 6
measure: Number of Newsletters Read/Downloaded
timeFrame: Month 6
measure: Program Process Evaluation
timeFrame: 6 months
measure: Number of Times Visiting the Site
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmina Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Resnicow K, Morabia A. The relation between body mass index and plasma total cholesterol in a multiracial sample of US schoolchildren. Am J Epidemiol. 1990 Dec;132(6):1083-90. doi: 10.1093/oxfordjournals.aje.a115751.