Clinical Trials /

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

NCT03223753

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ALTE1631
  • SECONDARY ID: NCI-2017-01219
  • SECONDARY ID: ALTE1631
  • SECONDARY ID: COG-ALTE1631
  • SECONDARY ID: ALTE1631
  • SECONDARY ID: R01CA193478
  • SECONDARY ID: UG1CA189955
  • NCT ID: NCT03223753

Conditions

  • Acute Lymphoblastic Leukemia in Remission

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVES:

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

      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 ALL (compared to the same web-based physical activity intervention
      without rewards or 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 ALL (compared to the same web-based
      physical activity intervention without rewards or 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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (Sqord monitor, limited version of Sqord websiteActive ComparatorPatients 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 (Sqord monitor, interactive-reward based Sqord website)ExperimentalPatients 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.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Patient must be a newly diagnosed ALL, in first remission
      
                -  Patient must have completed curative chemotherapy within past 6 months at a Childrens
                   Oncology Group (COG) institution
      
                -  Patients must have a performance status corresponding to Eastern Cooperative Oncology
                   Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age
      
                -  At the time of consent, patient or parent/guardian reports less than 420 minutes of
                   moderate to vigorous physical activity over the last week
      
                -  Patient must have access to a smart phone with Android 4.3 or later or iOS 7.1 or
                   later or computer (laptop/desktop) with a connection to the internet to create an
                   account and be able to sync the Sqord device (accelerometer)
      
                -  Patient and at least one parent/guardian are able to read and write English; at least
                   1 parent/guardian must be able to read and write English in order to assist the
                   patient with using their Sqord account
      
              Exclusion Criteria:
      
                -  Patients with previous hematopoietic stem cell transplant (HSCT)
      
                -  Patients with significant concurrent disease, illness, psychiatric disorder or social
                   issue that would compromise patient safety or compliance with protocol therapy, or
                   interfere with consent, study participation, follow up, or interpretation of study
                   results
      
                -  Female patients who are pregnant are not eligible; women of childbearing potential
                   require a negative pregnancy test
      
                -  Female patient who is postmenarcheal has agreed to use an effective contraceptive
                   method (including abstinence) for the duration of study participation
            
      Maximum Eligible Age:15 Years
      Minimum Eligible Age:8 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Physiologic cost index (PCI)
      Time Frame:Up to 24 weeks (end of intervention)
      Safety Issue:
      Description:Differences in PCI will be compared between groups at the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution.

      Secondary Outcome Measures

      Measure:Change in markers of cardiometabolic health
      Time Frame:Baseline up to 48 weeks post intervention
      Safety Issue:
      Description:Markers of Cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. Differences in these markers between randomized groups and the effects of group assignment on changes over time will be evaluated.
      Measure:Change in inflammation
      Time Frame:Baseline up to 48 weeks post intervention
      Safety Issue:
      Description:Markers of an Inflammatory state include High sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor alpha. Differences in these markers between groups and the effects of group assignment on changes over time will be evaluated.
      Measure:Change in quality of life assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale
      Time Frame:Baseline up to 48 weeks post intervention
      Safety Issue:
      Description:The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. Scores range from 0-100, higher is better.. There are four scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning).. Emotional, Social and School Functioning can be combined to create a psychosocial summary (summed and divided by total number of items). Differences between groups and the effects of group assignment on changes over time will be evaluated.
      Measure:Change in fatigue assessed using Pediatric Quality of Life Multidimensional Fatigue Scale
      Time Frame:Baseline up to 48 weeks post intervention
      Safety Issue:
      Description:The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. It has three dimensions, general fatigue, sleep/rest fatigue and cognitive fatigue. Scores range from 0-100 and items are summed and divided by the total to get the mean. Differences between groups and the effects of group assignment on changes over time will be evaluated.
      Measure:Change in school attendance assessed using parent report
      Time Frame:Baseline up to 48 weeks post intervention
      Safety Issue:
      Description:Differences between groups and the effects of group assignment on changes over time will be evaluated.
      Measure:Markers of cardiometabolic health
      Time Frame:Up to 48 weeks post intervention
      Safety Issue:
      Description:Markers of cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. It will be determined if the effect of an interactive web-based physical activity intervention on markers of cardiometabolic health is mediated by changes in fitness among children and adolescents following treatment for acute lymphoblastic leukemia. A causal inference approach will evaluate whether group assignment results in an improved outcome in the presence of a lower PCI. This requires decomposing the averaged total effect into indirect and direct effects of group assignment of on the cardiometabolic outcomes. A principal stratification method will be used that classifies participants into strata based on their performance on the PCI (mediator variable) for each group of the randomized intervention. Mediation analyses would then be based on intent-to-treat effects of group assignment on cardiometabolic health outcome within each strata.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Children's Oncology Group

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