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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01916 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ALTE2031 | Other Identifier | Children's Oncology Group | |
| COG-ALTE2031 | Other Identifier | DCP | |
| ALTE2031 | Other Identifier | CTEP | |
| U01CA246665 | U.S. NIH Grant/Contract | View source | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
PRIMARY OBJECTIVE:
I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
SECONDARY OBJECTIVES:
I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
OUTLINE: Participants are randomized to 1 of 2 groups.
INTERVENTION GROUP: Participants receive educational materials about physical activity.
INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit.
MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges.
CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (educational materials, Fitbit) | Active Comparator | Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks. |
|
| Intervention group (educational materials, goal set, Fitbit) | Experimental | See outline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive educational materials |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of moderate-to-vigorous physical activity (MVPA) per day | Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence intervals. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary fitness | Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. Participants complete the 2-Minute Step Test at baseline and 12 months post-baseline. Steps are counted during the test. Will report the mean difference in steps from baseline to 12 months, by arm, with corresponding 95% confidence intervals. | 12 months |
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Inclusion Criteria:
First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
Patients must have a life expectancy of > 1 year
Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
Ambulatory and no known medical contraindications to increasing physical activity
No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
Able to read and write English
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:
Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
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| Name | Affiliation | Role |
|---|---|---|
| Nina S Kadan-Lottick | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Health Strada Patient Care Center | Mobile | Alabama | 36604 | United States | ||
| Banner Children's at Desert |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39079612 | Derived | Beight LJ, Mendoza JA, Leisenring WM, Collier W, Olsen ME, Ross WL, Santiago-Rivera Y, Bryant S, Rotatori J, Ness KK, Hurtado-de-Mendoza A, Baker KS, Chow EJ, Kadan-Lottick NS. Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group. Contemp Clin Trials. 2024 Oct;145:107645. doi: 10.1016/j.cct.2024.107645. Epub 2024 Jul 28. |
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|
| FitBit | Device | Wear a Fitbit |
|
| Goal Setting | Other | Set goals |
|
| Health Promotion and Education | Other | Receive text message about goal setting |
|
| Media Intervention | Other | Follow Instagram group |
|
| Telephone-Based Intervention | Behavioral | Receive phone call about goal setting |
|
| Resting heart rate | Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor prior to the participant initiating the 2-Minute Step Test at baseline and 12 months. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Health-related quality of life (HRQOL) Global Functioning | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Global Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Health-related quality of life (HRQOL) Physical Functioning | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Physical Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Health-related quality of life (HRQOL) Social Functioning | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Social Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Health-related quality of life (HRQOL) Fatigue | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Fatigue score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Total cholesterol | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Total cholesterol will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| High density lipoprotein (HDL) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Low density lipoprotein (LDL) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. LDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Triglycerides | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Triglycerides will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Insulin (HOMA-IR) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HOMA-IR will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Hemoglobin A1c (HbA1c) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HbA1c will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| High sensitivity C-reactive protein (CRP) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. CRP will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. | 12 months |
| Mesa |
| Arizona |
| 85202 |
| 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 |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Mattel Children's Hospital UCLA | Los Angeles | California | 90095 | 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 |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93102 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | 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 |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Palms West Radiation Therapy | Loxahatchee Groves | Florida | 33470 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | 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 |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Corewell Health Children's | Royal Oak | Michigan | 48073 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | 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 |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | 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 |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | 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 |
| 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 |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Vannie Cook Children's Clinic | McAllen | Texas | 78503 | 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 |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | 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 |
| 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 |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D009937 | Organizational Objectives |
| D006293 | Health Promotion |
| 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 |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D006266 | Health Education |
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