NCT03223753

Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.

Detailed description

PRIMARY OBJECTIVE: I. To compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer. SECONDARY OBJECTIVES: I. To evaluate the effect of a rewards-based, socially interactive web-based physical activity intervention on markers of cardiometabolic health among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction). II. To evaluate the effect of a rewards-based, socially interactive, web-based physical activity intervention on physical activity, quality of life, fatigue, and school attendance among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction). III. To determine if the effect of a rewards-based, socially interactive, web-based physical activity intervention on markers of cardiometabolic health is mediated by changes in fitness among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of the app/website to get basic information related to their physical activity. Patients will not be told of the details of earning of monetary incentives. Their activity will be monitored during the 6 month intervention period and will receive all earned gift cards or prizes after the intervention period ends. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives. ARM II: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients randomized to this study arm. Patients will receive additional details about how to earn gift cards or prizes for engaging in the intervention and will be rewarded for all earned incentives throughout the 6 month intervention period. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives. After completion of study, patients are followed up at 24 and 48 weeks.

Conditions

• Carcinoma In Situ
• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Educational Intervention	Receive educational handouts about to physical activity
OTHER	Internet-Based Intervention	Access limited version of device app/website
OTHER	Internet-Based Intervention	Access full version of interactive reward-based device app/website
OTHER	Laboratory Biomarker Analysis	Correlative studies
DEVICE	Medical Device Usage and Evaluation	Wear physical activity tracking device
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-11-29
• Primary completion: 2025-03-31
• Completion: 2026-03-31
• First posted: 2017-07-21
• Last updated: 2025-04-18

Locations

118 sites across 2 countries: United States, Canada