Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission

Official Title

A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Acute Lymphoblastic Leukemia

Summary:

This randomized clinical trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with newly diagnosed acute lymphoblastic leukemia that shows a decrease in or disappearance of signs and symptoms. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.

Trial Description

Primary Outcome:

• Physiologic cost index (PCI)
• Secondary Outcome:
• Change in markers of cardiometabolic health
• Change in inflammation
• Change in quality of life assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale
• Change in fatigue assessed using Pediatric Quality of Life Multidimensional Fatigue Scale
• Change in school attendance assessed using parent report
• Markers of cardiometabolic health

PRIMARY OBJECTIVES:

• 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 rewards or structured social interaction on fitness among children and adolescents following treatment for acute lymphoblastic leukemia (ALL).

SECONDARY OBJECTIVES:

• 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 ALL (compared to the same web-based physical activity intervention without rewards or social interaction)
• 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 ALL (compared to the same web-based physical activity intervention without rewards or social interaction).
• 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 ALL (compared to the same web-based physical activity intervention without rewards or 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 Sqord activity monitor daily and upload data at least once a week to the Sqord website. Patients also access the limited version of Sqord website to get basic information related to their physical activity for 6 months.

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 Sqord activity monitor daily and upload data at least once a week to the Sqord website. Patients also access the full version of the interactive-reward based Sqord website to see their activity, earn activity points, see other Sqord player's activity, and interact with other Sqord members for 6 months. After completion of study, patients are followed up at 24 and 48 weeks.

View this trial on ClinicalTrials.gov