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RecruitingInterventionalPhase 2

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

NCT ID: NCT06410209Sponsor: Children's Oncology GroupLast updated: 2026-02-27

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

Sex: AllAge: 15 Years to 20 YearsHealthy volunteers: No
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 locations (76)

Banner Children's at Desert

Mesa, Arizona, 85202

Recruiting
Site Public Contact · Contact
Joseph C. Torkildson · Principal Investigator

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Recruiting
Site Public Contact · Contact
Alexandra M. Walsh · Principal Investigator

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Recruiting
Site Public Contact · Contact
David L. Becton · Principal Investigator

Kaiser Permanente Downey Medical Center

Downey, California, 90242

Recruiting
Site Public Contact · Contact
Lisa A. Mueller · Principal Investigator

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting
Site Public Contact · Contact
Rusha Bhandari · Principal Investigator

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

Recruiting
Site Public Contact · Contact
Jacqueline N. Casillas · Principal Investigator

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

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Site Public Contact · Contact
Satiro N. De Oliveira · Principal Investigator

Valley Children's Hospital

Madera, California, 93636

Recruiting
Site Public Contact · Contact
Ruetima Titapiwatanakun · Principal Investigator

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

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Site Public Contact · Contact
Natalie L. Wu · Principal Investigator

Kaiser Permanente-Oakland

Oakland, California, 94611

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Site Public Contact · Contact
Aarati V. Rao · Principal Investigator

Rady Children's Hospital - San Diego

San Diego, California, 92123

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Site Public Contact · Contact
William D. Roberts · Principal Investigator

Children's Hospital Colorado

Aurora, Colorado, 80045

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Site Public Contact · Contact
Jenna M. Demedis · Principal Investigator

Yale University

New Haven, Connecticut, 06520

Recruiting
Site Public Contact · Contact
Rozalyn L. Rodwin · Principal Investigator

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

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Site Public Contact · Contact
Vibhuti Agarwal · Principal Investigator

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

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Site Public Contact · Contact
Caileigh Pudela · Principal Investigator

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

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Site Public Contact · Contact
Emad K. Salman · Principal Investigator

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

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Site Public Contact · Contact
Iftikhar Hanif · Principal Investigator

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Recruiting
Site Public Contact · Contact
Vibhuti Agarwal · Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

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Site Public Contact · Contact
Meghan McCormick · Principal Investigator

Miami Cancer Institute

Miami, Florida, 33176

Recruiting
Site Public Contact · Contact
Matthew D. Hall · Principal Investigator

AdventHealth Orlando

Orlando, Florida, 32803

Recruiting
Site Public Contact · Contact
Fouad M. Hajjar · Principal Investigator

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Recruiting
Jaime M. Libes-Bander · Principal Investigator

Nemours Children's Hospital

Orlando, Florida, 32827

Recruiting
Site Public Contact · Contact
Vibhuti Agarwal · Principal Investigator

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504

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Site Public Contact · Contact
Jeffrey H. Schwartz · Principal Investigator

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701

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Site Public Contact · Contact
Jennifer B. Dean · Principal Investigator

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607

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Site Public Contact · Contact
Don E. Eslin · Principal Investigator

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

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Site Public Contact · Contact
Jordan G. Marchak · Principal Investigator

Memorial Health University Medical Center

Savannah, Georgia, 31404

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Site Public Contact · Contact
Andrew L. Pendleton · Principal Investigator

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

Recruiting
Site Public Contact · Contact
Jennifer L. Reichek · Principal Investigator

University of Illinois

Chicago, Illinois, 60612

Recruiting
Site Public Contact · Contact
Dipti S. Dighe · Principal Investigator

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Recruiting
Site Public Contact · Contact
Gregory P. Brandt · Principal Investigator

Riley Hospital for Children

Indianapolis, Indiana, 46202

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Site Public Contact · Contact
Sandeep Batra · Principal Investigator

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Recruiting
Site Public Contact · Contact
Bassem I. Razzouk · Principal Investigator

Blank Children's Hospital

Des Moines, Iowa, 50309

Recruiting
Site Public Contact · Contact
Samantha L. Mallory · Principal Investigator

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting
Site Public Contact · Contact
James T. Badgett · Principal Investigator

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Recruiting
Site Public Contact · Contact
Maria C. Velez-Yanguas · Principal Investigator

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Recruiting
Site Public Contact · Contact
Craig Lotterman · Principal Investigator

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Recruiting
Site Public Contact · Contact
Jason M. Fixler · Principal Investigator

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

Recruiting
Site Public Contact · Contact
Allen I. Stering · Principal Investigator

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Recruiting
Site Public Contact · Contact
Michael K. Richards · Principal Investigator

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

Recruiting
Site Public Contact · Contact
Jill C. Beck · Principal Investigator

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Recruiting
Site Public Contact · Contact
Jill C. Beck · Principal Investigator

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Recruiting
Site Public Contact · Contact
Alan K. Ikeda · Principal Investigator

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

Recruiting
Site Public Contact · Contact
Alan K. Ikeda · Principal Investigator

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Recruiting
Site Public Contact · Contact
Alan K. Ikeda · Principal Investigator

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

Recruiting
Site Public Contact · Contact
Alan K. Ikeda · Principal Investigator

Renown Regional Medical Center

Reno, Nevada, 89502

Recruiting
Site Public Contact · Contact
Alan K. Ikeda · Principal Investigator

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Site Public Contact · Contact
Katharine R. Lange · Principal Investigator

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

Recruiting
Site Public Contact · Contact
Nibal A. Zaghloul · Principal Investigator

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

Recruiting
Jessica M. Valdez · Principal Investigator

Maimonides Medical Center

Brooklyn, New York, 11219

Recruiting
Site Public Contact · Contact
Mahmut Y. Celiker · Principal Investigator

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467

Recruiting
Site Public Contact · Contact
Alice Lee · Principal Investigator

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting
Site Public Contact · Contact
Jessica M. Sun · Principal Investigator

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Recruiting
Site Public Contact · Contact
Sarah Supples · Principal Investigator

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Recruiting
Site Public Contact · Contact
Rene Y. McNall-Knapp · Principal Investigator

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Recruiting
Site Public Contact · Contact
Jason M. Glover · Principal Investigator

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Recruiting
Site Public Contact · Contact
Lisa M. McGregor · Principal Investigator

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

Recruiting
Site Public Contact · Contact
Gregory E. Halligan · Principal Investigator

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Recruiting
Site Public Contact · Contact
Aniket Saha · Principal Investigator

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Recruiting
Site Public Contact · Contact
Susan E. Spiller · Principal Investigator

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Recruiting
Site Public Contact · Contact
Kirsten K. Ness · Principal Investigator

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

Recruiting
Site Public Contact · Contact
Clinton M. Carroll · Principal Investigator

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Recruiting
Shannon M. Cohn · Principal Investigator

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

Recruiting
Site Public Contact · Contact
Nkechi I. Mba · Principal Investigator

Medical City Dallas Hospital

Dallas, Texas, 75230

Recruiting
Site Public Contact · Contact
Maurizio L. Ghisoli · Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Recruiting
Ksenya Shliakhtsitsava · Principal Investigator

El Paso Children's Hospital

El Paso, Texas, 79905

Recruiting
Site Public Contact · Contact
Benjamin Carcamo · Principal Investigator

Cook Children's Medical Center

Fort Worth, Texas, 76104

Recruiting
Donald T. Beam · Principal Investigator

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Recruiting
Site Public Contact · Contact
Maria M. Gramatges · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Site Public Contact · Contact
Najat C. Daw · Principal Investigator

Children's Hospital of San Antonio

San Antonio, Texas, 78207

Recruiting
Site Public Contact · Contact
Julie Voeller · Principal Investigator

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

Recruiting
Jose M. Esquilin · Principal Investigator

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Recruiting
Site Public Contact · Contact
Shafqat Shah · Principal Investigator

Seattle Children's Hospital

Seattle, Washington, 98105

Recruiting
Site Public Contact · Contact
Sarah E. Leary · Principal Investigator

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Recruiting
Site Public Contact · Contact
Judy L. Felgenhauer · Principal Investigator

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Site Public Contact · Contact
Jenny Hoag · Principal Investigator