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

February 26, 2026 updated by: Children's Oncology Group

Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • University Pediatric Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 787-474-0333
        • Principal Investigator:
          • Maria E. Echevarria
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Recruiting
        • Banner Children's at Desert
        • Contact:
          • Site Public Contact
          • Phone Number: 480-412-3100
        • Principal Investigator:
          • Joseph C. Torkildson
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 602-546-0920
        • Principal Investigator:
          • Alexandra M. Walsh
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 501-364-7373
        • Principal Investigator:
          • David L. Becton
    • California
      • Downey, California, United States, 90242
        • Recruiting
        • Kaiser Permanente Downey Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 626-564-3455
        • Principal Investigator:
          • Lisa A. Mueller
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Rusha Bhandari
        • Contact:
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's and Women's Hospital Long Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 562-933-5600
        • Principal Investigator:
          • Jacqueline N. Casillas
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mattel Children's Hospital UCLA
        • Contact:
          • Site Public Contact
          • Phone Number: 310-825-6708
        • Principal Investigator:
          • Satiro N. De Oliveira
      • Madera, California, United States, 93636
        • Recruiting
        • Valley Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ruetima Titapiwatanakun
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Aarati V. Rao
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospital Oakland
        • Principal Investigator:
          • Natalie L. Wu
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
          • Site Public Contact
          • Phone Number: 858-966-5934
        • Principal Investigator:
          • William D. Roberts
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Jenna M. Demedis
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Rozalyn L. Rodwin
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Caileigh Pudela
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Principal Investigator:
          • Emad K. Salman
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Iftikhar Hanif
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Meghan McCormick
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • Matthew D. Hall
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Principal Investigator:
          • Jaime M. Libes-Bander
        • Contact:
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Contact:
        • Principal Investigator:
          • Vibhuti Agarwal
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Fouad M. Hajjar
      • Pensacola, Florida, United States, 32504
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jennifer B. Dean
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Contact:
        • Principal Investigator:
          • Don E. Eslin
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Contact:
        • Principal Investigator:
          • Jordan G. Marchak
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Contact:
        • Principal Investigator:
          • Andrew L. Pendleton
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital-Chicago
        • Principal Investigator:
          • Jennifer L. Reichek
        • Contact:
          • Site Public Contact
          • Phone Number: 773-880-4562
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Dipti S. Dighe
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
        • Principal Investigator:
          • Sandeep Batra
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension Saint Vincent Indianapolis Hospital
        • Contact:
        • Principal Investigator:
          • Bassem I. Razzouk
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Blank Children's Hospital
        • Contact:
        • Principal Investigator:
          • Samantha L. Mallory
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • James T. Badgett
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital New Orleans
        • Principal Investigator:
          • Maria C. Velez-Yanguas
        • Contact:
          • Site Public Contact
          • Phone Number: 504-894-5377
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Craig Lotterman
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • Jason M. Fixler
        • Contact:
          • Site Public Contact
          • Phone Number: 410-601-9083
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
        • Principal Investigator:
          • Allen I. Stering
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Principal Investigator:
          • Michael K. Richards
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Phone Number: 402-955-3949
        • Principal Investigator:
          • Jill C. Beck
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Jill C. Beck
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Katharine R. Lange
        • Contact:
          • Site Public Contact
          • Phone Number: 551-996-2897
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Saint Peter's University Hospital
        • Contact:
        • Principal Investigator:
          • Nibal A. Zaghloul
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Jessica M. Valdez
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 718-765-2500
        • Principal Investigator:
          • Mahmut Y. Celiker
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Alice Lee
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Jessica M. Sun
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Sarah Supples
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Emanuel Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2560
        • Principal Investigator:
          • Jason M. Glover
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 717-531-6012
        • Principal Investigator:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, United States, 19134
        • Recruiting
        • Saint Christopher's Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 215-427-8991
        • Principal Investigator:
          • Gregory E. Halligan
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • BI-LO Charities Children's Cancer Center
        • Principal Investigator:
          • Aniket Saha
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • East Tennessee Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 865-541-8266
        • Principal Investigator:
          • Susan E. Spiller
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Saint Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Kirsten K. Ness
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Children's Hospital at TriStar Centennial
        • Contact:
          • Site Public Contact
          • Phone Number: 615-342-1919
        • Principal Investigator:
          • Clinton M. Carroll
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Principal Investigator:
          • Shannon M. Cohn
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Driscoll Children's Hospital
        • Contact:
        • Principal Investigator:
          • Nkechi I. Mba
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Ksenya Shliakhtsitsava
        • Contact:
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 972-566-5588
        • Principal Investigator:
          • Maurizio L. Ghisoli
      • El Paso, Texas, United States, 79905
        • Recruiting
        • El Paso Children's Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Carcamo
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Najat C. Daw
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Maria M. Gramatges
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Children's Hospital of San Antonio
        • Contact:
        • Principal Investigator:
          • Julie Voeller
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Shafqat Shah
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Principal Investigator:
          • Jose M. Esquilin
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-987-2000
        • Principal Investigator:
          • Sarah E. Leary
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Judy L. Felgenhauer
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Principal Investigator:
          • Jenny Hoag
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must be ≥ 15 years and < 21 years at the time of enrollment
  • 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). Note: Certain stem cell transplant procedures are excluded. Reminder: Children's Oncology Group (COG) therapeutic trial participation is not required
  • Completed all chemotherapy and/or radiation therapy in the last 3-36 months. This includes completion of all oral (e.g., tyrosine kinase inhibitors) and/or maintenance chemotherapy
  • Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed and documented via the study-specific Physical Activity Worksheet. Note: See the case report forms packet on the COG study web page for 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 Spanish or English
  • Self-identify as Hispanic, Latino/Latina/Latinx

Exclusion Criteria:

  • Patients with previous allogeneic hematopoietic stem cell transplant (HSCT) are excluded. Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
  • Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded. Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
  • Participants who were enrolled in ALTE2031 (Step by Step) cannot enroll in ALTE2321. Participants who were enrolled in ALTE2321 stage 1 (cultural tailoring) cannot enroll to participate in stage 2 (RCT)
  • All patients and/or their parents or legal guardians must sign a written informed consent. Note: Informed consent may be obtained electronically/online if allowed by local site policy and institutional review board (IRB)/research ethics board (REB) of record
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stage 2, Group II (Fitbit)
Patients wear a Fitbit physical activity tracker daily for 12 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Other: Medical Device Usage and Evaluation
Wear a research grade activity measuring device
Experimental: Stage 1 (Fitbit, interview)
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)
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Goal Setting
Set physical activity goals
Other: Interview
Participate in a one-on-one interview
Other: Media Intervention
View private social media peer support group content
Other: Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Other: Medical Device Usage and Evaluation
Wear a research grade activity measuring device
Other: Text Message-Based Navigation Intervention
Receive text messages
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Other: Text Message-Based Navigation Intervention
Receive reminders
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Experimental: Stage 2, Group I (Fitbit, goal setting, peer support)

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.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Goal Setting
Set physical activity goals
Other: Interview
Participate in a one-on-one interview
Other: Media Intervention
View private social media peer support group content
Other: Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Other: Medical Device Usage and Evaluation
Wear a research grade activity measuring device
Other: Text Message-Based Navigation Intervention
Receive text messages
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Other: Text Message-Based Navigation Intervention
Receive reminders
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Other: Reward
Receive badges
Other: Discussion
Participate in Zoom meetings with peers to discuss physical activity
Other Names:
  • Discuss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate to vigorous physical activity (MVPA)
Time Frame: Baseline to 11-12 weeks post randomization
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global functioning
Time Frame: Baseline to 11-12 weeks post randomization
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
Fatigue
Time Frame: Baseline to 11-12 weeks post randomization
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
Sedentary time
Time Frame: Baseline to 11-12 weeks post randomization
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
Physical functioning
Time Frame: Baseline to 11-12 weeks post randomization
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
Time Frame: Baseline to 11-12 weeks post randomization
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiopulmonary fitness
Time Frame: At baseline and up to final evaluation at 11-12 weeks post-randomization
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
Time Frame: At baseline and up to final evaluation at 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Investigators

  • Principal Investigator: Jason A Mendoza, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTE2321 (Other Identifier: CTEP)
  • UG1CA189955 (U.S. NIH Grant/Contract)
  • NCI-2024-03609 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • COG-ALTE2321 (Other Identifier: DCP)
  • R01CA274450 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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