mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

Conditions
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Cancer, Physical Activity

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Intervention<br>* Individual session, physical activity tracker, online intervention<br>|
| No Intervention: Wait List Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate | 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 | Percentage of eligible participants who agreed to participate. | Through completion of study enrollment, an average of 6 months. | 
| Retention rate at 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 | Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group. | 6 months | 
| Satisfaction with intervention | Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire. | 6 months | 
| Adherence to physical activity monitoring | Number of days physical activity tracked, as measured by Fitbit. | Through study completion, 6 months | 
| Physical activity: objective | 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 | 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 | 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 | Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months. | Baseline, 3 months, 6 months | 
| Intrinsic motivation | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent and young adult, cancer survivor