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Trial record 1 of 1 for:    alte1631
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Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

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ClinicalTrials.gov Identifier: NCT03223753
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date October 19, 2021
Actual Study Start Date  ICMJE August 14, 2017
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
Physiologic cost index (PCI) [ Time Frame: Up to 24 weeks (end of intervention) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Change in cardiometabolic health assessed using Functional Assessments [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Change in fatigue assessed using Pediatric Quality of Life Multidimensional Fatigue Scale [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Change in inflammation assessed using High Sensitivity C-Reactive Protein [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Change in quality of life assessed using Pediatric Quality of Life 4.0 Generic Core Scale [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Change in school attendance assessed using parent report [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Markers of cardiometabolic health [ Time Frame: Up to 48 weeks post intervention ]
    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 be used to evaluate whether or not group assignment results in an improved outcome in the presence of a lower PCI. This requires decomposing the averaged total effect into indirect (mediation effects of fitness) and direct effects of group assignment of on the cardiometabolic outcomes. A principal stratification method that classifies participants into strata based on their performance on the PCI (mediator variable) for each group of the randomized intervention.
  • Physiologic cost index (PCI) [ Time Frame: Up to 24 weeks (end of intervention) ]
    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.
  • Change in inflammation assessed using Interleukin-6 [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Change in inflammation assessed using Tumor Necrosis Factor-Alpha [ Time Frame: Baseline up to 48 weeks post intervention ]
    Differences between groups and the effects of group assignment on changes over time will be evaluated.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
  • Change in markers of cardiometabolic health [ Time Frame: Baseline up to 48 weeks post intervention ]
    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.
  • Change in inflammation [ Time Frame: Baseline up to 48 weeks post intervention ]
    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.
  • Change in quality of life [ Time Frame: Baseline up to 48 weeks post intervention ]
    Will be assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale. 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.
  • Change in fatigue [ Time Frame: Baseline up to 48 weeks post intervention ]
    Will be assessed using Pediatric Quality of Life Multidimensional Fatigue Scale. 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.
  • Change in school attendance [ Time Frame: Baseline up to 48 weeks post intervention ]
    Will be assessed using parent report. Differences between groups and the effects of group assignment on changes over time will be evaluated.
  • Markers of cardiometabolic health [ Time Frame: Up to 48 weeks post intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer
Official Title  ICMJE A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Carcinoma In Situ
  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm
Intervention  ICMJE
  • Other: Educational Intervention
    Receive educational handouts about to physical activity
    Other Names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • 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 Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Active Comparator: Arm I (tracking device, limited version of device)
    Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear 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 device app/website to get basic information related to their physical activity for 6 months.
    Interventions:
    • Other: Educational Intervention
    • Other: Internet-Based Intervention
    • Other: Laboratory Biomarker Analysis
    • Device: Medical Device Usage and Evaluation
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Arm II (tracking device, interactive-reward based device)
    Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear 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 for 6 months.
    Interventions:
    • Other: Educational Intervention
    • Other: Internet-Based Intervention
    • Other: Laboratory Biomarker Analysis
    • Device: Medical Device Usage and Evaluation
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
384
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission
  • Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 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 and at least one parent/guardian are able to read and write English, Spanish, and/or French; at least 1 parent/guardian must be able to read and write English, Spanish, and/or French in order to assist the patient with using their physical activity tracking device account
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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 and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation
  • Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g. unresolved posterior fossa syndrome) are not eligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223753
Other Study ID Numbers  ICMJE ALTE1631
NCI-2017-01219 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALTE1631 ( Other Identifier: Children's Oncology Group )
COG-ALTE1631 ( Other Identifier: DCP )
ALTE1631 ( Other Identifier: CTEP )
R01CA193478 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kirsten K Ness Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP