Recruiting

Phase 2

Physical Activity ProgramA 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

Sponsor:

Children's Oncology Group

Code:

NCT06410209

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Not accepted

Interventions

Discussion

Goal Setting

Interview

Media Intervention

Study Details

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06410209

Start date

Oct 15, 2024

Status verified date

Feb, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Not accepted

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 Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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)

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.

active comparator: Stage 2, Group II (Fitbit)

Patients wear a Fitbit physical activity tracker daily for 12 weeks.

Interventions

Discussion

Participate in Zoom meetings with peers to discuss physical activity

Goal Setting

Set physical activity goals

Interview

Participate in a one-on-one interview

Interview

Ancillary studies

Media Intervention

View private social media peer support group content

Medical Device Usage and Evaluation

Wear a Fitbit physical activity tracker

Medical Device Usage and Evaluation

Wear a research grade activity measuring device

Questionnaire Administration

Ancillary studies

Reward

Receive badges

Text Message-Based Navigation Intervention

Receive text messages

Text Message-Based Navigation Intervention

Receive reminders

Primary outcome measure

Moderate to vigorous physical activity (MVPA) [ Time Frame: Baseline to 11-12 weeks post randomization ]

Central Contacts and Locations

Locations

Banner Children's at Desert

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Site Public Contact

480-412-3100

Principal Investigator:

Joseph C. Torkildson

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Alexandra M. Walsh

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

David L. Becton

Kaiser Permanente Downey Medical Center

Recruiting

Downey, California, United States, 90242

Contacts

Site Public Contact

626-564-3455

Principal Investigator:

Lisa A. Mueller

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673 becomingapatient@coh.org

Principal Investigator:

Rusha Bhandari

Miller Children's and Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

Contacts

Site Public Contact

562-933-5600

Principal Investigator:

Jacqueline N. Casillas

Mattel Children's Hospital UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Site Public Contact

310-825-6708

Principal Investigator:

Satiro N. De Oliveira

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Site Public Contact

559-353-3000 Research@valleychildrens.org

Principal Investigator:

Ruetima Titapiwatanakun

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Site Public Contact

510-428-3264 PedOncRschOAK@ucsf.edu

Principal Investigator:

Natalie L. Wu

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Site Public Contact

858-966-5934

Principal Investigator:

William D. Roberts

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

303-764-5056 josh.b.gordon@nsmtp.kp.org

Principal Investigator:

Jenna M. Demedis

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Rozalyn L. Rodwin

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Caileigh Pudela

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Site Public Contact

239-343-5333 molly.arnstrom@leehealth.org

Principal Investigator:

Emad K. Salman

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847 OHR@mhs.net

Principal Investigator:

Iftikhar Hanif

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Meghan McCormick

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Matthew D. Hall

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Site Public Contact

407-303-2090 FH.Cancer.Research@flhosp.org

Principal Investigator:

Fouad M. Hajjar

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Site Public Contact

321-841-5357 Jennifer.spinelli@orlandohealth.com

Principal Investigator:

Jaime M. Libes-Bander

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Jeffrey H. Schwartz

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Site Public Contact

727-767-4784 Ashley.Repp@jhmi.edu

Principal Investigator:

Jennifer B. Dean

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

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

813-357-0849 jennifer.manns@baycare.org

Principal Investigator:

Don E. Eslin

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Site Public Contact

404-785-0232 Olivia.Floyd@choa.org

Principal Investigator:

Jordan G. Marchak

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Site Public Contact

912-350-7887 Lorraine.OHara@hcahealthcare.com

Principal Investigator:

Andrew L. Pendleton

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Jennifer L. Reichek

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Dipti S. Dighe

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Gregory P. Brandt

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

Sandeep Batra

Ascension Saint Vincent Indianapolis Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Site Public Contact

317-338-2194 research@stvincent.org

Principal Investigator:

Bassem I. Razzouk

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-8912 samantha.mallory@unitypoint.org

Principal Investigator:

Samantha L. Mallory

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

James T. Badgett

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Site Public Contact

504-894-5377

Principal Investigator:

Maria C. Velez-Yanguas

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Site Public Contact

504-842-8084 Elisemarie.curry@ochsner.org

Principal Investigator:

Craig Lotterman

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-9083

Principal Investigator:

Jason M. Fixler

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Allen I. Stering

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Site Public Contact

612-813-5913 pauline.mitby@childrensmn.org

Principal Investigator:

Michael K. Richards

Children's Hospital and Medical Center of Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-955-3949

Principal Investigator:

Jill C. Beck

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941 unmcrsa@unmc.edu

Principal Investigator:

Jill C. Beck

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Katharine R. Lange

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Site Public Contact

732-745-8600 kcovert@saintpetersuh.com

Principal Investigator:

Nibal A. Zaghloul

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348 HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Jessica M. Valdez

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Site Public Contact

718-765-2500

Principal Investigator:

Mahmut Y. Celiker

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866 eskwak@montefiore.org

Principal Investigator:

Alice Lee

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Jessica M. Sun

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Sarah Supples

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator:

Rene Y. McNall-Knapp

Legacy Emanuel Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Site Public Contact

503-413-2560

Principal Investigator:

Jason M. Glover

Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Site Public Contact

717-531-6012

Principal Investigator:

Lisa M. McGregor

Saint Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Site Public Contact

215-427-8991

Principal Investigator:

Gregory E. Halligan

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Aniket Saha

East Tennessee Childrens Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Site Public Contact

865-541-8266

Principal Investigator:

Susan E. Spiller

Saint Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Site Public Contact

888-226-4343 referralinfo@stjude.org

Principal Investigator:

Kirsten K. Ness

The Children's Hospital at TriStar Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Site Public Contact

615-342-1919

Principal Investigator:

Clinton M. Carroll

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Site Public Contact

512-628-1902 TXAUS-DL-SFCHemonc.research@ascension.org

Principal Investigator:

Shannon M. Cohn

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Site Public Contact

361-694-5311 Crystal.DeLosSantos@dchstx.org

Principal Investigator:

Nkechi I. Mba

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Ksenya Shliakhtsitsava

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Site Public Contact

915-298-5444 ranjan.bista@ttuhsc.edu

Principal Investigator:

Benjamin Carcamo

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

682-885-2103 CookChildrensResearch@cookchildrens.org

Principal Investigator:

Donald T. Beam

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354 burton@bcm.edu

Principal Investigator:

Maria M. Gramatges

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

877-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Najat C. Daw

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Site Public Contact

210-704-2894 bridget.medina@christushealth.org

Principal Investigator:

Julie Voeller

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-575-6240 Vinod.GidvaniDiaz@hcahealthcare.com

Principal Investigator:

Jose M. Esquilin

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-450-3800 phoresearchoffice@uthscsa.edu

Principal Investigator:

Shafqat Shah

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Site Public Contact

866-987-2000

Principal Investigator:

Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Site Public Contact

800-228-6618 HopeBeginsHere@providence.org

Principal Investigator:

Judy L. Felgenhauer

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727 MACCCTO@mcw.edu

Principal Investigator:

Jenny Hoag

More Information

Sponsor

Children's Oncology Group

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-02-27.