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 completed.

Public Health Relevance

REVELANCE This project is designed to evaluate the effectiveness of a 24 week rewards-based physical activity intervention, delivered via an interactive website for children with acute lymphoblastic leukemia (ALL), beginning just after completion of curative chemotherapy, on fitness, biomarkers of cardiometabolic health, physical activity, quality of life, fatigue and school attendance. This proposal has relevance for public health as it will test the efficacy of a portable, cost-effective intervention designed to prevent/remediate known late effects of treatment among children with ALL. This intervention will be tested using the infrastructure of the Children's Oncology Group to enroll children across multiple study sites. If successful, it provides a model for not only children treated for ALL, but for other children whose acute disease and necessary treatments have late effects that interfere with future health, function and quality of life.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA193478-01A1
Application #
9175959
Study Section
Special Emphasis Panel (ZRG1-PSE-K (57)R)
Program Officer
Perna, Frank
Project Start
2016-07-01
Project End
2021-06-30
Budget Start
2016-07-01
Budget End
2017-06-30
Support Year
1
Fiscal Year
2016
Total Cost
$937,623
Indirect Cost
$404,098
Name
St. Jude Children's Research Hospital
Department
Type
DUNS #
067717892
City
Memphis
State
TN
Country
United States
Zip Code
38105