A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)

NCT ID: NCT04188002

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-25
• Study Completion Date: 2018-08-01

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.

Conditions

Nutrition; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control - Fruit and Vegetable

Participants in this arm will receive usual care.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)

Physical Activity Intervention

Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.

Group Type: OTHER

Intervention Physical Activity

Intervention Type: BEHAVIORAL

4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.

Interventions

Intervention Physical Activity

4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.

Intervention Type: BEHAVIORAL

Usual Care

4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmina Valle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 2260540 (View on PubMed)

Other Identifiers

16-1897

Identifier Type: -

Identifier Source: org_study_id