Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
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.
Arms & interventions
- OtherDiscussion
Participate in Zoom meetings with peers to discuss physical activity
- OtherGoal Setting
Set physical activity goals
- OtherInterview
Participate in a one-on-one interview
- OtherInterview
Ancillary studies
- OtherMedia Intervention
View private social media peer support group content
- OtherMedical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
- OtherMedical Device Usage and Evaluation
Wear a research grade activity measuring device
- OtherQuestionnaire Administration
Ancillary studies
- OtherReward
Receive badges
- OtherText Message-Based Navigation Intervention
Receive text messages
- OtherText Message-Based Navigation Intervention
Receive reminders
Outcome measures
Primary
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.
Time frame: Baseline to 11-12 weeks post randomization
Secondary
Sedentary time
Time frame: Baseline to 11-12 weeks post randomization
Global functioning
Time frame: Baseline to 11-12 weeks post randomization
Physical functioning
Time frame: Baseline to 11-12 weeks post randomization
Social functioning
Time frame: Baseline to 11-12 weeks post randomization
Fatigue
Time frame: Baseline to 11-12 weeks post randomization
Eligibility criteria
Study locations (76)
Banner Children's at Desert
Mesa, Arizona, 85202
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Kaiser Permanente Downey Medical Center
Downey, California, 90242
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Valley Children's Hospital
Madera, California, 93636
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Kaiser Permanente-Oakland
Oakland, California, 94611
Rady Children's Hospital - San Diego
San Diego, California, 92123
Children's Hospital Colorado
Aurora, Colorado, 80045
Yale University
New Haven, Connecticut, 06520
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
AdventHealth Orlando
Orlando, Florida, 32803
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Nemours Children's Hospital
Orlando, Florida, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Memorial Health University Medical Center
Savannah, Georgia, 31404
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
University of Illinois
Chicago, Illinois, 60612
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Riley Hospital for Children
Indianapolis, Indiana, 46202
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Blank Children's Hospital
Des Moines, Iowa, 50309
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Renown Regional Medical Center
Reno, Nevada, 89502
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Maimonides Medical Center
Brooklyn, New York, 11219
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Duke University Medical Center
Durham, North Carolina, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Medical City Dallas Hospital
Dallas, Texas, 75230
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
El Paso Children's Hospital
El Paso, Texas, 79905
Cook Children's Medical Center
Fort Worth, Texas, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Seattle Children's Hospital
Seattle, Washington, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226