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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03223753
Other study ID # ALTE1631
Secondary ID NCI-2017-01219AL
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 29, 2017
Est. completion date March 31, 2025

Study information

Verified date May 2024
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 384
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Intervention
Receive educational handouts about to physical activity
Internet-Based Intervention
Access limited version of device app/website
Internet-Based Intervention
Access full version of interactive reward-based device app/website
Laboratory Biomarker Analysis
Correlative studies
Device:
Medical Device Usage and Evaluation
Wear physical activity tracking device
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Canada Kingston Health Sciences Centre Kingston Ontario
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Janeway Child Health Centre Saint John's Newfoundland and Labrador
Canada Hospital for Sick Children Toronto Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Texas Tech University Health Sciences Center-Amarillo Amarillo Texas
United States C S Mott Children's Hospital Ann Arbor Michigan
United States Mission Hospital Asheville North Carolina
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Children's Hospital of Alabama Birmingham Alabama
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Tufts Children's Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States T C Thompson Children's Hospital Chattanooga Tennessee
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States Columbia Regional Columbia Missouri
United States Prisma Health Richland Hospital Columbia South Carolina
United States Nationwide Children's Hospital Columbus Ohio
United States Driscoll Children's Hospital Corpus Christi Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Children's Hospital of Michigan Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Kaiser Permanente Downey Medical Center Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States El Paso Children's Hospital El Paso Texas
United States Broward Health Medical Center Fort Lauderdale Florida
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States East Carolina University Greenville North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States Miller Children's and Women's Hospital Long Beach Long Beach California
United States Norton Children's Hospital Louisville Kentucky
United States Palms West Radiation Therapy Loxahatchee Groves Florida
United States UMC Cancer Center / UMC Health System Lubbock Texas
United States Medical Center of Central Georgia Macon Georgia
United States Valley Children's Hospital Madera California
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Vannie Cook Children's Clinic McAllen Texas
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Banner Children's at Desert Mesa Arizona
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States West Virginia University Healthcare Morgantown West Virginia
United States The Children's Hospital at TriStar Centennial Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Children's Hospital New Orleans New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States Kaiser Permanente-Oakland Oakland California
United States UCSF Benioff Children's Hospital Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Children's Hospital and Medical Center of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Arnold Palmer Hospital for Children Orlando Florida
United States Nemours Children's Hospital Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Advocate Children's Hospital-Park Ridge Park Ridge Illinois
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Phoenix Childrens Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Legacy Emanuel Children's Hospital Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Renown Regional Medical Center Reno Nevada
United States Carilion Children's Roanoke Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Children's Hospital of San Antonio San Antonio Texas
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Rady Children's Hospital - San Diego San Diego California
United States Seattle Children's Hospital Seattle Washington
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Tampa General Hospital Tampa Florida
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Banner University Medical Center - Tucson Tucson Arizona
United States New York Medical College Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Saint Mary's Hospital West Palm Beach Florida
United States Alfred I duPont Hospital for Children Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiologic cost index (PCI) 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. Up to 24 weeks (end of intervention)
Secondary Change in markers of cardiometabolic health 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. Baseline up to 48 weeks post intervention
Secondary Change in inflammation 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. Baseline up to 48 weeks post intervention
Secondary Change in quality of life 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. Baseline up to 48 weeks post intervention
Secondary Change in fatigue 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. Baseline up to 48 weeks post intervention
Secondary Change in school attendance Will be assessed using parent report. Differences between groups and the effects of group assignment on changes over time will be evaluated. Baseline up to 48 weeks post intervention
Secondary Markers of cardiometabolic health 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. Up to 48 weeks post intervention
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