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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Physical Activity
Nutrition

Treatments

Behavioral: Intervention Physical Activity
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT04188002
16-1897

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

49 participants in 2 patient groups

Control - Fruit and Vegetable
Other group
Description:
Participants in this arm will receive usual care.
Treatment:
Other: Usual Care
Physical Activity Intervention
Other group
Description:
Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.
Treatment:
Behavioral: Intervention Physical Activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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