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

NCT06410209 | Recruiting Phase 2 DMC

• 5 other identifiers: ALTE2321NCI-2024-03609COG-ALTE2321R01CA274450UG1CA189955
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 77

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 11-12 weeks post randomization

Secondary Outcomes (5)

• Sedentary time

  Baseline to 11-12 weeks post randomization

• Global functioning

  Baseline to 11-12 weeks post randomization

• Physical functioning

  Baseline to 11-12 weeks post randomization

• Social functioning

  Baseline to 11-12 weeks post randomization

• Fatigue

  Baseline to 11-12 weeks post randomization

Other Outcomes (2)

• Change in cardiopulmonary fitness

  At baseline and up to final evaluation at 11-12 weeks post-randomization

• Change in resting heart rate

  At baseline and up to final evaluation at 11-12 weeks post-randomization

Study Arms (3)

Stage 1 (Fitbit, interview)

EXPERIMENTAL

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: Goal Setting; Other: Interview; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention

Stage 2, Group I (Fitbit, goal setting, peer support)

EXPERIMENTAL

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: Discussion; Other: Goal Setting; Other: Interview; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Reward; Other: Text Message-Based Navigation Intervention

Stage 2, Group II (Fitbit)

ACTIVE COMPARATOR

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

Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Goal Setting OTHER

Set physical activity goals

Stage 1 (Fitbit, interview); Stage 2, Group I (Fitbit, goal setting, peer support)

Interview OTHER

Participate in a one-on-one interview

Stage 1 (Fitbit, interview)

Media Intervention OTHER

View private social media peer support group content

Stage 1 (Fitbit, interview); Stage 2, Group I (Fitbit, goal setting, peer support)

Medical Device Usage and Evaluation OTHER

Wear a Fitbit physical activity tracker

Stage 1 (Fitbit, interview); Stage 2, Group I (Fitbit, goal setting, peer support); Stage 2, Group II (Fitbit)

Questionnaire Administration OTHER

Ancillary studies

Stage 1 (Fitbit, interview); Stage 2, Group I (Fitbit, goal setting, peer support); Stage 2, Group II (Fitbit)

Reward OTHER

Receive badges

Stage 2, Group I (Fitbit, goal setting, peer support)

Text Message-Based Navigation Intervention OTHER

Receive text messages

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Stage 1 (Fitbit, interview)

Discussion OTHER

Participate in Zoom meetings with peers to discuss physical activity

Also known as: Discuss

Stage 2, Group I (Fitbit, goal setting, peer support)

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead

Study Sites (77)

Banner Children's at Desert

Mesa, Arizona, 85202, United States

RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

RECRUITING

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

RECRUITING

Valley Children's Hospital

Madera, California, 93636, United States

RECRUITING

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

MedStar Georgetown University Hospital

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

RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

RECRUITING

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

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

Tampa, Florida, 33607, United States

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

RECRUITING

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

RECRUITING

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

RECRUITING

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

RECRUITING

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

El Paso Children's Hospital

El Paso, Texas, 79905, United States

RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

University Pediatric Hospital

San Juan, 00926, Puerto Rico

RECRUITING

MeSH Terms

Interventions

Organizational Objectives; Interviews as Topic

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jason A Mendoza

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and participating site staff are blinded.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (76); PR (1)