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

Physical Activity Clinical Trial

— eWellness  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188002
• Other study ID #: 16-1897
• Status: Completed
• Phase: N/A
• Start date: March 25, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 1, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Nutrition
• Physical Activity

Intervention

Behavioral:
• Intervention Physical Activity
4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.

Other:
• Usual Care
4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Fruit and Vegetable Score	Fruit and vegetable consumption will be adapted from a 35-item measure used in a trial for US Blacks adapted from a 35-item measure for US Southern blacks that measures frequency of intake during the previous month. Score measures can range from 2-24. Positive or better outcomes are reflected by higher mean fruit and vegetable scores.	Month 6
Primary	Summary Fruit and Vegetable Score	The frequency of fruit and vegetable intake will be measured during the previous month, using a 2-item measure (How many servings of fruits do you eat each day?) and a similar question for vegetables that assesses usual vegetable intake. Scores can range from 0-N with higher scores indicating more fruit and/or vegetable intake.	Month 6
Primary	Metabolic Equivalent Task Hours (METs) for Physical Activity	Moderate to physical activity will be assessed and frequency of different types of activity, with response options of: don't do, 1-3 times/month, 1-2 times/week, 3-4 times/week, or 5 or more times/week. Items include various types of activities gathered from an 11-item instrument modified for cultural appropriateness from a previous study. For each activity, participants estimate duration as either <20 minutes or 20 or more minutes per session. Physical activity is then calculated in terms of metabolic equivalent task hours (METs) per week. MET values for energy expenditure were assigned to each activity based on validated instruments.21 MET-hours are computed by multiplying frequency times duration (converted to hours/week) times the MET value. Reported physical activity time can range from 0 minutes - 6 hours or more for reported sedentary behaviors. Higher reported values equate to better reported outcomes of increased physical activity for participants.	Month 6
Secondary	Recruitment rate	Recruitment rate is defined as the number of screened participants that meet eligibility criteria divided by the number of individuals screened.	Month 6
Secondary	Percentage of Participants Completing the Intervention and Follow-Up Assessments	Retention	Month 6
Secondary	Number of Newsletters Read/Downloaded	Participant Adherence	Month 6
Secondary	Program Process Evaluation	This will be assessed with process evaluation questions at follow-up survey and metrics of website use (e.g. number of times visiting site). Questions will ask about participants' perceptions and experiences with the intervention and may provide valuable information about how to modify the programs for future use in this population. Measures will be adapted from those used in our previous studies and assess ease of use, intervention instructions and length, attractiveness, perceived personal relevance, recall, credibility, novelty, and usefulness for making healthy changes, and satisfaction with intervention components. Higher values will represent better outcomes for program process evaluation.	6 months
Secondary	Number of Times Visiting the Site	An evaluation of website metrics will be conducted to assess program acceptability.	6 months