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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223753
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment Phase
Carcinoma In Situ Malignant Neoplasm Other: Educational Intervention Other: Internet-Based Intervention Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: Arm I (Sqord monitor, limited version of Sqord website
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.
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 Sqord website

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Sqord activity monitor
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (Sqord monitor, interactive-reward based Sqord website)
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.
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 full version of interactive reward-based Sqord website

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Sqord activity monitor
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
    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.

  4. Change in fatigue assessed using Pediatric Quality of Life Multidimensional Fatigue Scale [ Time Frame: Baseline up to 48 weeks post intervention ]
    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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223753


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kirsten K Ness Children's Oncology Group
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03223753    
Other Study ID Numbers: 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 )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type