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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2022
  • participants needed
    384
  • sponsor
    Children's Oncology Group
Updated on 26 May 2021
Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (5.6 mi away) Contact
+88 other location
cancer
carcinoma
chemotherapy regimen
primary cancer

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.

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 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. 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 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. 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.

Details
Condition Cancer, Carcinoma in Situ, Carcinoma, Vulvar Dysplasia and Carcinoma, Cancer/Tumors, Ewing's Family Tumors, Acute Lymphoblastic Leukemia in Remission, Advanced Malignancies, Malignant Solid Tumor, Malignant Solid Neoplasm, Cancer (Pediatric), Neoplasms, Hematopoietic and Lymphoid System Neoplasm, in situ carcinoma, cancer in situ
Treatment laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, educational intervention, internet-based intervention, Monitoring Device, Medical Device Usage and Evaluation
Clinical Study IdentifierNCT03223753
SponsorChildren's Oncology Group
Last Modified on26 May 2021

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