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Proposed is a multi-site, randomized controlled trial (RCT) which will enroll 384 adolescent and young adult childhood cancer (AYA) survivors currently ages 15.0-20.9 years who are 3-36 months off therapy and not meeting physical activity (PA) guidelines. The 12-month trial will test the efficacy of a 6-month intensive multi-level PA intervention combining a wearable PA tracker (intrapersonal level) with integration of activity data leading to individualized goal setting by text (intrapersonal level) and a private Instagram account serving as a virtual peer support group of survivors (interpersonal and community level) followed by a 6-month maintenance phase to improve PA in AYA survivors.
A nationwide sample of patients drawn from rural, urban, community, and academic centers will be recruited from patients treated at sites in the Children's Oncology Group consortium of >200 hospitals. To examine the behavioral intervention's efficacy, the following Specific Aims and Hypotheses (H) will be used:
Aim 1: To increase PA (primary outcome) among AYA survivors who do not meet PA guidelines. H1.1: Intervention participants will have greater increases in PA than control patients as assessed by accelerometry at 12 months post-randomization. H1.2: Increases in the psychological constructs of competence, autonomy, and relatedness will mediate the relationship between the intervention and changes in PA. Exploratory H: The intervention will have a greater impact among survivors without private health insurance compared to those with private health insurance.
Aim 2: To improve biomarkers predictive of cardiometabolic health (secondary outcome) among AYA survivors who do not meet PA guidelines. H2.1: Intervention participants will have greater improvements in cardiopulmonary fitness, resting heart rate, markers of glucose metabolism, lipid levels, and inflammatory and adipokine profiles than control patients as assessed by the physiologic cost Index, heart rate monitor, and fasting blood assays at 12 months post-randomization. H2.2: Increases in PA will mediate the relationship between the intervention and changes in biomarkers.
Aim 3: To improve health-related quality of life (secondary outcome) among AYA survivors who do not meet PA guidelines. H3.1: Intervention participants will have greater improvements in global, physical, and social functioning and fatigue than control patients as assessed by validated self-report instruments at 12 months post-randomization. H3.2: Increases in PA will mediate the relationship between the intervention and changes in health-related quality of life.
PA Tracker, Social Media
Not yet recruiting
Published on BioPortfolio: 2019-09-19T03:56:44-0400
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