||5R01CA193478-06 Interpret this number
||St. Jude Children'S Research Hospital
||Web-Based Physical Activity Intervention for Children with All
The five year survival rate among children diagnosed with acute lymphoblastic leukemia (ALL) has surpassed
90%. Unfortunately, cure is not without consequences. ALL 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. Because children with leukemia
are likely to adopt a sedentary lifestyle that persists long into survivorship, and because a sedentary lifestyle
may perpetuate or exacerbate many of the complications experienced by ALL survivors, 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. This proposal is designed to access the
resources of the Children's Oncology Group (COG) and complements ongoing therapeutic protocols. It will draw
upon the existing infrastructure and expertise of the COG to recruit a sample of children as they complete
treatment for childhood ALL. The primary goals of this study are to evaluate the effects of a rewards-based
physical activity intervention, delivered via an interactive website for children with ALL, during a six month period
beginning any time during the first three months after the end of curative chemotherapy, on fitness, biomarkers
of cardiometabolic health, inflammation, adipokine status, quality of life and school attendance. We also
plan to evaluate if the effects of the intervention on markers of cardiometabolic health are mediated by changes
in fitness. To achieve this goal we have designed a two-arm, prospective, randomized study with a rewards-
based intervention group (N=192) and a control group (N=192). The control group will receive educational
materials encouraging physical activity, including information about activity modifications for common
neuromusculoskeletal deficits (e.g. neuropathy, weakness), and an activity monitor to record physical activity
levels. The intervention group will receive the same educational materials, the activity monitor, and access to a
rewards-based interactive website designed to motivate increased levels of physical activity. Intervention group
participants will receive points based on physical activity levels. Points are redeemed for small gift cards ($5.00)
during the course of the study. Based on our pilot study, the average child/adolescent will earn eight gift
cards. Individual physical activity levels are uploaded to the website (with acknowledgement of the data upload
for control group participants, and with an interactive video game-type dashboard for intervention group
participants when the activity monitor is connected to a computer). Rewards and encouragement are provided
by the website based on the intervention participants' measured physical activity levels. Children who are initially
less active still earn points as the rewards system is based on individual baseline physical activity. Evaluation
time points are planned at baseline, after intervention, and six months and one year after the intervention is
Design and methods of a randomized web-based physical activity intervention among children with cancer: A report from the Children's Oncology Group.
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Contemporary clinical trials, 2022 Nov; 122, p. 106961.