A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study
Start Date
10/15/2024
Completion Date
9/15/2027
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 15 years to 20 years
Interventions
Discussion
Goal Setting
Interview
Interview
Media Intervention
Medical Device Usage and Evaluation
Medical Device Usage and Evaluation
Questionnaire Administration
Reward
Text Message-Based Navigation Intervention
Text Message-Based Navigation Intervention
Conditions
Locations
Banner Children's at Desert
Mesa, Arizona 85202
United States
Phoenix Childrens Hospital
Phoenix, Arizona 85016
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
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
Rady Children's Hospital - San Diego
San Diego, California 92123
United States
Children's Hospital Colorado
Aurora, Colorado 80045
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
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
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
Nemours Children's Clinic - Pensacola
Pensacola, Florida 32504
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida 33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia 30329
United States
Memorial Health University Medical Center
Savannah, Georgia 31404
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
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
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Children's Hospital New Orleans
New Orleans, Louisiana 70118
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota 55404
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
Saint Peter's University Hospital
New Brunswick, New Jersey 08901
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Maimonides Medical Center
Brooklyn, New York 11219
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Legacy Emanuel Children's Hospital
Portland, Oregon 97227
United States
Penn State Children's Hospital
Hershey, Pennsylvania 17033
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
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
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas 78411
United States
Medical City Dallas Hospital
Dallas, Texas 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
El Paso Children's Hospital
El Paso, Texas 79905
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
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
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
Seattle Children's Hospital
Seattle, Washington 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United States
University Pediatric Hospital
San Juan, 00926
Puerto Rico