ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03223753
Previous Study | Return to List | Next Study

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

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 : August 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Childhood Acute Lymphoblastic Leukemia in Remission 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 OBJECTIVES:

I. To evaluate the effect of an interactive web-based physical activity intervention on fitness among children and adolescents following treatment for acute lymphoblastic leukemia (ALL).

SECONDARY OBJECTIVES:

I. To evaluate the effect of an interactive web-based physical activity intervention on markers of cardiometabolic health among children and adolescents following treatment for ALL.

II. To evaluate the effect of an interactive web-based physical activity intervention on physical activity, quality of life, fatigue, and school attendance among children and adolescents following treatment for ALL.

III. To determine 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 ALL.

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.


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 Acute Lymphoblastic Leukemia
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022


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. 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.

  2. 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.

  3. 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.

  4. 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.

  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 ]
    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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patient must be a newly diagnosed ALL, in first remission
  • Patient must have completed curative chemotherapy within past 90 days 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

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
United States, Pennsylvania
Childrens Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kirsten K. Ness    901-595-5157    kiri.ness@stjude.org   
Principal Investigator: Kirsten K. Ness         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kirsten Ness Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03223753     History of Changes
Other Study ID Numbers: ALTE1631
NCI-2017-01219 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALTE1631 ( Other Identifier: Childrens Oncology Group )
COG-ALTE1631 ( Other Identifier: DCP )
R01CA193478 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases