Current Research Studies

COG ALTE1631, A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Cancer

ALTE1631, Web-based Physical Activity Study

  • Condition: Survivorship
  • Phase: III
  • ID: NCT03223753

What is the goal of the study?

The five year survival rate among children diagnosed with cancer has surpassed 84%. Unfortunately, cure is not without consequences. Childhood cancer survivors are at elevated risk for obesity, low bone mineral density, cardiomyopathy, peripheral neuropathy, and altered psychosocial functioning. Research is critically needed to provide survivors with tools to improve their long term health. Children with cancer are likely to adopt a sedentary lifestyle that persists long into survivorship, and a sedentary lifestyle may perpetuate or exacerbate many of the complications experienced by survivors. Therefore, a portable and generalizable intervention that promotes physical activity and impacts fitness and biomarkers of cardiometabolic health in the first year after treatment may be of particular benefit. The primary goals of this study are to evaluate the effects of a 6 month long rewards-based physical activity intervention on fitness, biomarkers of cardiometabolic health, inflammation, adipokine status, quality of life and school attendance. The study plans to evaluate if the effect of the intervention on markers of cardiometabolic health is mediated by changes in fitness. To achieve this goal the study will utilize a two-arm, prospective, randomized study with an intervention group (N=192) and a control group (N=192). Both groups will receive educational materials encouraging physical activity, including information about activity modifications for common neuro-musculoskeletal deficits (e.g. neuropathy, weakness), and an activity monitor to record physical activity levels and access to a web-based physical activity intervention designed to motivate increased levels of physical activity. Individual physical activity levels are uploaded from the activity monitor to the website. Both groups will receive rewards based on physical activity levels. Credits are a type of reward that can be earned to receive small gift cards or monetarily equivalent prizes. Only the intervention group will receive additional details about how to earn this type of reward. Other rewards and encouragement are provided by the website based on the participants? measured physical activity levels. Children who are initially less active still earn rewards as the system is based on individual baseline physical activity. The intervention group will receive full access to a rewards-based interactive website. Full access allows those randomized to the intervention group to interact with other participants. The control group will receive limited access to the same website. The control group will be limited to only see themselves and their own progress. The intervention participants will receive gift cards or prizes during the course of the intervention period. The control group will receive all earned gift cards or prizes at the end of the intervention period. Evaluation time points are planned at baseline, at the end of the 6 month intervention, 6 and 12 months after the end of the intervention.

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team: