- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03386383
mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers (THRIVE)
May 30, 2023 updated by: UNC Lineberger Comprehensive Cancer Center
The purpose of this study is to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adolescent and young adult (AYA) survivors are not meeting recommended physical activity guidelines for cancer survivors, and few interventions to date have focused specifically on promoting physical activity among AYAs or capitalized on new technologies to deliver them.
This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among AYA survivors compared to a delayed intervention control group.
This project will focus on how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance autonomous motivation, and promote social support in a mobile health behavioral intervention that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors.
Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently age 18-39.
AYA cancer survivors will be recruited from the three comprehensive cancer centers in North Carolina to participate in this study.
The behavioral intervention will consist of an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback emails.
Assessments of objectively-measured physical activity and other outcomes will be completed at baseline, 3, and 6 months.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with cancer (excluding basal cell skin cancer) at age 15 or older
- Currently age 18-39
- Are 0 to 10 years post active cancer treatment (i.e., current hormonal treatments or maintenance therapies are permissible)
- Able to speak, read and write English
- Have access to the Internet and computer on at least a weekly basis
- Possession and usage of an Internet e-mail address or willingness to sign up for a free email account
- Have active Facebook account
- Willing to be randomized to either arm
Exclusion Criteria:
- History of heart attack or stroke within past 6 months
- Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
- Have a pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
- Are already adhering to the American Cancer Society's recommendation of ≥150 minutes of moderate-intensity exercise per week (<150 minutes/week)
- Current participation in another physical activity or weight control program
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- Plans for major surgery (e.g., breast reconstruction) during the study time frame
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants will receive an initial individual session, physical activity tracker, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group immediately after baseline assessments.
|
Individual session, physical activity tracker, online intervention
|
No Intervention: Wait List Control
Participants will receive a physical activity tracker and be advised to maintain their current activity.
After 3 months, participants will receive an initial individual session, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accrual rate
Time Frame: Through completion of study enrollment, an average of 6 months.
|
Number of participants who agreed to participate divided by the number of months of recruitment.
|
Through completion of study enrollment, an average of 6 months.
|
Participation rate
Time Frame: Through completion of study enrollment, an average of 6 months.
|
Percentage of eligible participants who agreed to participate.
|
Through completion of study enrollment, an average of 6 months.
|
Retention rate at 3 months
Time Frame: 3 months
|
Number of intervention participants who completed 3-month measures divided by the number who consented to participate.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention rate at 6 months
Time Frame: 6 months
|
Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.
|
6 months
|
Satisfaction with intervention
Time Frame: 6 months
|
Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.
|
6 months
|
Adherence to physical activity monitoring
Time Frame: Through study completion, 6 months
|
Number of days physical activity tracked, as measured by Fitbit.
|
Through study completion, 6 months
|
Physical activity: objective
Time Frame: Baseline, 3 months, 6 months
|
Change in objective levels of physical activity, as measured by accelerometry (Actigraph), from baseline to 3 months, and 3 months to 6 months.
|
Baseline, 3 months, 6 months
|
Physical activity: self-report
Time Frame: Baseline, 3 months, 6 months
|
Change in self-report levels of physical activity, as measured by the Godin Leisure Time Exercise Questionnaire, from baseline to 3 months, and 3 months to 6 months.
|
Baseline, 3 months, 6 months
|
Sedentary behavior: self-report
Time Frame: Baseline, 3 months, 6 months
|
Change in self-report levels of sedentary behavior, as measured by the Marshall Sitting Time Questionnaire, from baseline to 3 months, and 3 months to 6 months.
|
Baseline, 3 months, 6 months
|
Weight
Time Frame: Baseline, 3 months, 6 months
|
Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.
|
Baseline, 3 months, 6 months
|
Intrinsic motivation
Time Frame: Baseline, 3 months, 6 months
|
Change in intrinsic motivation, as measured by the intrinsic motivation subscale of the Treatment Self-Regulation Questionnaire for Exercise, from baseline to 3 months, and 3 months to 6 months.
Responses to four items comprising intrinsic motivation subscale are averaged to yield a score from 1 to 7, with higher values representing higher intrinsic motivation.
|
Baseline, 3 months, 6 months
|
Self-efficacy for exercise
Time Frame: Baseline, 3 months, 6 months
|
Change in self-efficacy for exercise, as measured by the Self-Efficacy and Exercise Habits Survey, from baseline to 3 months, and 3 months to 6 months.
Responses for two subscales (Sticking to it, Making time for exercise) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.
|
Baseline, 3 months, 6 months
|
Social support for exercise
Time Frame: Baseline, 3 months, 6 months
|
Change in social support for exercise, as measured by the Social Support for Exercise Survey, from baseline to 3 months, and 3 months to 6 months.
Responses for three factors (Family participation, Friend participation, Friends on social networking sites participation), ranging from 1 to 5, are summed, with higher values representing higher social support for exercise.
|
Baseline, 3 months, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posttraumatic growth
Time Frame: Baseline, 3 months, 6 months
|
Change in posttraumatic growth, as measured by the Short Form of the Posttraumatic Growth Inventory, from baseline to 3 months, and 3 months to 6 months.
Responses range from 0 to 5 and yield an overall score and subscale scores for relating to others, new possibilities, personal strength, spiritual change, and appreciation of life.
Items are summed, with higher scores reflecting more positive change (i.e., posttraumatic growth).
|
Baseline, 3 months, 6 months
|
Positive psychosocial illness impact
Time Frame: Baseline, 3 months, 6 months
|
Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Positive (4a), from baseline to 3 months, and 3 months to 6 months.
Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more positive psychosocial impact.
|
Baseline, 3 months, 6 months
|
Negative psychosocial illness impact
Time Frame: Baseline, 3 months, 6 months
|
Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Negative (4a), from baseline to 3 months, and 3 months to 6 months.
Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more negative psychosocial impact.
|
Baseline, 3 months, 6 months
|
Positive affect
Time Frame: Baseline, 3 months, 6 months
|
Changes in positive affect, as measured by the NIH Toolbox Positive Affect Short Form, from baseline to 3 months, and 3 months to 6 months.
|
Baseline, 3 months, 6 months
|
Social network orientation
Time Frame: Baseline, 3 months, 6 months
|
Changes in positive affect, as measured by the Network Orientation Scale, from baseline to 3 months, and 3 months to 6 months.
Responses to 20 items range from 1 to 4. Items are summed (range: 20 to 80), with higher scores representing a more negative social network orientation.
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carmina G. Valle, PhD, MPH, University of North Carolina, Chapel Hill
- Principal Investigator: John M. Salsman, PhD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2018
Primary Completion (Actual)
March 25, 2019
Study Completion (Actual)
March 25, 2019
Study Registration Dates
First Submitted
November 13, 2017
First Submitted That Met QC Criteria
December 20, 2017
First Posted (Actual)
December 29, 2017
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 30, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- LCCC1709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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