Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (tracking device, limited version of device) | Active Comparator | 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. |
|
| Arm II (tracking device, interactive-reward based device) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive educational handouts about to physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirsten K Ness | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Banner Children's at Desert |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36228982 | Derived | Ware ME, Kadan-Lottick NS, Devidas M, Terrell S, Chow EJ, Ehrhardt MJ, Hardy KK, Chemaitilly W, Hein W, Winick N, Teachey D, Esbenshade A, Armenian SH, Partin RE, Ness KK. Design and methods of a randomized web-based physical activity intervention among children with cancer: A report from the Children's Oncology Group. Contemp Clin Trials. 2022 Nov;122:106961. doi: 10.1016/j.cct.2022.106961. Epub 2022 Oct 10. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2026 | |
| Unrelease | Apr 2, 2026 | |
| Release | Apr 2, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Internet-Based Intervention | Other | Access limited version of device app/website |
|
| Internet-Based Intervention | Other | Access full version of interactive reward-based device app/website |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Medical Device Usage and Evaluation | Device | Wear physical activity tracking device |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mesa |
| Arizona |
| 85202 |
| United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Palms West Radiation Therapy | Loxahatchee Groves | Florida | 33470 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | United States |
| Atrium Health Navicent | Macon | Georgia | 31201 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | 79106 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| UMC Cancer Center / UMC Health System | Lubbock | Texas | 79415 | United States |
| Vannie Cook Children's Clinic | McAllen | Texas | 78503 | United States |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Carilion Children's | Roanoke | Virginia | 24014 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | United States |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Reset | Apr 23, 2026 |
| Release | May 13, 2026 |
| Reset | Jun 8, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2026 | Apr 2, 2026 | |||
| Apr 2, 2026 | Apr 23, 2026 | |||
| May 13, 2026 | Jun 8, 2026 | |||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided