Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03609 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ALTE2321 | Other Identifier | Children's Oncology Group | |
| COG-ALTE2321 | Other Identifier | DCP | |
| ALTE2321 | Other Identifier | CTEP | |
| R01CA274450 | 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
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial tests the impact of a culturally-tailored home-based physical activity program on physical fitness in Hispanic or Latino/Latina adolescent and young adult (AYA) childhood cancer survivors. After treatment for cancer, some AYA survivors experience long-term effects from the cancer and its treatment including weight gain, fatigue and decreased physical fitness. Hispanic or Latino/Latina survivors may have a higher risk of these effects compared to non-Hispanics. Regular physical activity helps maintain healthy weight, energy levels and overall health. Participating in a culturally-tailored home-based physical activity program may help increase physical activity in Hispanic or Latino/Latina AYA childhood cancer survivors.
PRIMARY OBJECTIVES:
I. Use an iterative approach to develop a culturally-tailored multilevel remote-based physical activity (PA) intervention among a total of 20 Latinx adolescent and young adult survivors of childhood cancer (AYA survivors), 8-12 whose preferred language is English and 8-12 whose preferred language is Spanish, using the StepByStep intervention as a starting point. (Stage 1) II. Conduct a randomized controlled trial (RCT) to test the potential efficacy of the culturally-tailored remote-based PA intervention (versus [vs.] Fitbit PA tracker only) with respect to the primary outcome of moderate to vigorous physical activity (MVPA) measured with a validated, wearable Fitbit PA tracker over 12 weeks among a separate group of 170 Latinx AYA survivors whose preferred language is Spanish or English (n=85 per randomization group) and who do not meet PA guidelines at timepoint (T) 1. The control group will receive a Fitbit only. (Stage 2)
SECONDARY OBJECTIVES:
I. Among the patients enrolled to the RCT component of the study, evaluate the potential efficacy of randomization to the intervention group relative to control group with respect to decreasing sedentary time as assessed by a Fitbit PA tracker.
II. Evaluate potential efficacy of randomization to the active intervention group with respect to improvement in reported health-related quality of life.
EXPLORATORY OBJECTIVES:
I. Evaluate potential efficacy of randomization to the active intervention group with respect to physiological measurements predictive of cardiometabolic health.
II. Determine the acceptability of and guidance on improving the intervention phases in preparation for a fully powered, long term RCT by conducting two rounds of post-trial qualitative interviews among participants in the intervention Group n=12-15 for the intensive intervention phase and n=12-15 for the maintenance intervention phase. Preferences and barriers for an additional diet and nutrition component will also be explored.
OUTLINE:
STAGE 1: Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months.
STAGE 2: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION):
INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, receive badges, and participate in a monthly Zoom meeting with their peers to discuss physical activity for 12 weeks. Patients may optionally choose a physical activity partner. Partners wear a Fitbit physical activity tracker and receive educational materials about supporting the participant.
MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks. In addition, patients may continue to have their physical activity partner support them as in the Intensive Phase.
GROUP II (CONTROL): Patients wear a Fitbit physical activity tracker daily for 12 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 (Fitbit, interview) | Experimental | Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months. (COMPLETE 10/30/2025) |
|
| Stage 2, Group I (Fitbit, goal setting, peer support) | Experimental | INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, receive badges, and participate in a monthly Zoom meeting with their peers to discuss physical activity for 12 weeks. Patients may optionally choose a physical activity partner. Partners wear a Fitbit physical activity tracker and receive educational materials about supporting the participant. MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks. In addition, patients may continue to have their physical activity partner support them as in the Intensive Phase. |
|
| Stage 2, Group II (Fitbit) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Other | Participate in Zoom meetings with peers to discuss physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moderate to vigorous physical activity (MVPA) | MVPA will be measured by active minutes using Fitbit. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary time | Sedentary time as measured by FitBit. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
| Global functioning |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiopulmonary fitness | Change in cardiopulmonary fitness will be assessed by Fitbit cardio fitness score and heart rate. | At baseline and up to final evaluation at 11-12 weeks post-randomization |
| Change in resting heart rate |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason A Mendoza | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Children's at Desert | Recruiting | Mesa | Arizona | 85202 | United States |
Not provided
Not provided
Not provided
Not provided
Investigators and participating site staff are blinded.
| Active Comparator |
Patients wear a Fitbit physical activity tracker daily for 12 weeks. |
|
| Goal Setting | Other | Set physical activity goals |
|
| Interview | Other | Participate in a one-on-one interview |
|
| Interview | Other | Ancillary studies |
|
| Media Intervention | Other | View private social media peer support group content |
|
| Medical Device Usage and Evaluation | Other | Wear a Fitbit physical activity tracker |
|
| Medical Device Usage and Evaluation | Other | Wear a research grade activity measuring device |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Reward | Other | Receive badges |
|
| Text Message-Based Navigation Intervention | Other | Receive text messages |
|
|
| Text Message-Based Navigation Intervention | Other | Receive reminders |
|
|
Global functioning will be measured using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. |
| Baseline to 11-12 weeks post randomization |
| Physical functioning | Physical functioning will be measured using Spanish language versions of the PedsQL 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
| Social functioning | Social functioning will be measured using Spanish language versions of the PedsQL 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
| Fatigue | Fatigue will be measured using the18-item PedsQL 4.0 Multidimensional Fatigue Scale in Spanish or English. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
Change in resting heart rate will be measured by Fitbit cardio fitness score and heart rate.
| At baseline and up to final evaluation at 11-12 weeks post-randomization |
| Phoenix Childrens Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202-3591 | United States |
|
| Kaiser Permanente Downey Medical Center | Recruiting | Downey | California | 90242 | United States |
|
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
|
| Miller Children's and Women's Hospital Long Beach | Recruiting | Long Beach | California | 90806 | United States |
|
| Mattel Children's Hospital UCLA | Recruiting | Los Angeles | California | 90095 | United States |
|
| Valley Children's Hospital | Recruiting | Madera | California | 93636 | United States |
|
| UCSF Benioff Children's Hospital Oakland | Recruiting | Oakland | California | 94609 | United States |
|
| Kaiser Permanente-Oakland | Recruiting | Oakland | California | 94611 | United States |
|
| Rady Children's Hospital - San Diego | Recruiting | San Diego | California | 92123 | United States |
|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
|
| Alfred I duPont Hospital for Children | Recruiting | Wilmington | Delaware | 19803 | United States |
|
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
|
| Golisano Children's Hospital of Southwest Florida | Recruiting | Fort Myers | Florida | 33908 | United States |
|
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Recruiting | Hollywood | Florida | 33021 | United States |
|
| Nemours Children's Clinic-Jacksonville | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
|
| Miami Cancer Institute | Recruiting | Miami | Florida | 33176 | United States |
|
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
|
| Arnold Palmer Hospital for Children | Recruiting | Orlando | Florida | 32806 | United States |
|
| Nemours Children's Hospital | Recruiting | Orlando | Florida | 32827 | United States |
|
| Nemours Children's Clinic - Pensacola | Recruiting | Pensacola | Florida | 32504 | United States |
|
| Johns Hopkins All Children's Hospital | Recruiting | St. Petersburg | Florida | 33701 | United States |
|
| Saint Joseph's Hospital/Children's Hospital-Tampa | Recruiting | Tampa | Florida | 33607 | United States |
|
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Recruiting | Atlanta | Georgia | 30329 | United States |
|
| Memorial Health University Medical Center | Recruiting | Savannah | Georgia | 31404 | United States |
|
| Lurie Children's Hospital-Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
|
| University of Illinois | Recruiting | Chicago | Illinois | 60612 | United States |
|
| Southern Illinois University School of Medicine | Recruiting | Springfield | Illinois | 62702 | United States |
|
| Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| Ascension Saint Vincent Indianapolis Hospital | Recruiting | Indianapolis | Indiana | 46260 | United States |
|
| Blank Children's Hospital | Recruiting | Des Moines | Iowa | 50309 | United States |
|
| University of Kentucky/Markey Cancer Center | Recruiting | Lexington | Kentucky | 40536 | United States |
|
| Children's Hospital New Orleans | Recruiting | New Orleans | Louisiana | 70118 | United States |
|
| Ochsner Medical Center Jefferson | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
|
| Walter Reed National Military Medical Center | Recruiting | Bethesda | Maryland | 20889-5600 | United States |
|
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting | Minneapolis | Minnesota | 55404 | United States |
|
| Children's Hospital and Medical Center of Omaha | Recruiting | Omaha | Nebraska | 68114 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| University Medical Center of Southern Nevada | Recruiting | Las Vegas | Nevada | 89102 | United States |
|
| Sunrise Hospital and Medical Center | Recruiting | Las Vegas | Nevada | 89109 | United States |
|
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Recruiting | Las Vegas | Nevada | 89135 | United States |
|
| Summerlin Hospital Medical Center | Recruiting | Las Vegas | Nevada | 89144 | United States |
|
| Renown Regional Medical Center | Recruiting | Reno | Nevada | 89502 | United States |
|
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Saint Peter's University Hospital | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| University of New Mexico Cancer Center | Recruiting | Albuquerque | New Mexico | 87106 | United States |
|
| Maimonides Medical Center | Recruiting | Brooklyn | New York | 11219 | United States |
|
| Montefiore Medical Center - Moses Campus | Recruiting | The Bronx | New York | 10467 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Legacy Emanuel Children's Hospital | Recruiting | Portland | Oregon | 97227 | United States |
|
| Penn State Children's Hospital | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Saint Christopher's Hospital for Children | Recruiting | Philadelphia | Pennsylvania | 19134 | United States |
|
| BI-LO Charities Children's Cancer Center | Recruiting | Greenville | South Carolina | 29605 | United States |
|
| East Tennessee Childrens Hospital | Recruiting | Knoxville | Tennessee | 37916 | United States |
|
| Saint Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
|
| The Children's Hospital at TriStar Centennial | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Dell Children's Medical Center of Central Texas | Recruiting | Austin | Texas | 78723 | United States |
|
| Driscoll Children's Hospital | Recruiting | Corpus Christi | Texas | 78411 | United States |
|
| Medical City Dallas Hospital | Recruiting | Dallas | Texas | 75230 | United States |
|
| UT Southwestern/Simmons Cancer Center-Dallas | Recruiting | Dallas | Texas | 75390 | United States |
|
| El Paso Children's Hospital | Recruiting | El Paso | Texas | 79905 | United States |
|
| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
|
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Children's Hospital of San Antonio | Recruiting | San Antonio | Texas | 78207 | United States |
|
| Methodist Children's Hospital of South Texas | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| Providence Sacred Heart Medical Center and Children's Hospital | Recruiting | Spokane | Washington | 99204 | United States |
|
| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| University Pediatric Hospital | Recruiting | San Juan | 00926 | Puerto Rico |
|
| ID | Term |
|---|---|
| D009937 | Organizational Objectives |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided