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

Titre officiel

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

Sommaire:

Cet essai clinique avec répartition aléatoire évalue la mesure dans laquelle les interventions en ligne concernant l’activité physique sont efficaces pour améliorer la santé à long terme des enfants et des adolescents qui viennent de recevoir un diagnostic de leucémie lymphoblastique aiguë dont les signes et symptômes diminuent ou sont en train de disparaître. La pratique régulière d’activités physiques à la suite du traitement d’un cancer peut contribuer à maintenir un poids santé et à améliorer le niveau d’énergie et la santé globale.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov

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