A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness) (eWellness)
Primary Purpose
Nutrition, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Physical Activity
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Nutrition
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control - Fruit and Vegetable
Physical Activity Intervention
Arm Description
Participants in this arm will receive usual care.
Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Recruitment rate
Recruitment rate is defined as the number of screened participants that meet eligibility criteria divided by the number of individuals screened.
Percentage of Participants Completing the Intervention and Follow-Up Assessments
Retention
Number of Newsletters Read/Downloaded
Participant Adherence
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.
Number of Times Visiting the Site
An evaluation of website metrics will be conducted to assess program acceptability.
Full Information
NCT ID
NCT04188002
First Posted
December 3, 2019
Last Updated
December 3, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT04188002
Brief Title
A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
Acronym
eWellness
Official Title
A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Texas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Physical Activity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Fruit and Vegetable
Arm Type
Other
Arm Description
Participants in this arm will receive usual care.
Arm Title
Physical Activity Intervention
Arm Type
Other
Arm Description
Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Physical Activity
Intervention Description
4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)
Primary Outcome Measure Information:
Title
Mean Fruit and Vegetable Score
Description
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.
Time Frame
Month 6
Title
Summary Fruit and Vegetable Score
Description
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.
Time Frame
Month 6
Title
Metabolic Equivalent Task Hours (METs) for Physical Activity
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Recruitment rate is defined as the number of screened participants that meet eligibility criteria divided by the number of individuals screened.
Time Frame
Month 6
Title
Percentage of Participants Completing the Intervention and Follow-Up Assessments
Description
Retention
Time Frame
Month 6
Title
Number of Newsletters Read/Downloaded
Description
Participant Adherence
Time Frame
Month 6
Title
Program Process Evaluation
Description
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.
Time Frame
6 months
Title
Number of Times Visiting the Site
Description
An evaluation of website metrics will be conducted to assess program acceptability.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmina Valle, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2260540
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.
Results Reference
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A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
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