Culturally-tailored mobile and social media program to increase physical activity in Hispanic/Latino adolescent and young adult childhood cancer survivors.
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 project will test whether a culturally tailored home-based physical activity program delivered via mobile tools and social media can help Hispanic/Latino adolescent and young adult childhood cancer survivors become more active.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 15 Years to 20 Years |
| Sex | All |
| Sponsor | Children's Oncology Group Research network |
| Drugs / interventions | CAR T, chimeric antigen receptor, chemotherapy, radiation |
| Locations | 77 sites (Mesa, Arizona and 76 other locations) |
| Trial ID | NCT06410209 on ClinicalTrials.gov |
What this trial studies
The program is developed in two stages: first, an iterative process with about 20 Latinx AYA survivors (balanced by English and Spanish preference) to adapt the StepByStep intervention for cultural relevance and remote delivery. In stage two, a randomized controlled trial will enroll 170 Latinx AYA survivors who currently do not meet physical activity guidelines and randomize them to the culturally-tailored remote intervention versus a Fitbit-only control for 12 weeks. The primary outcome is change in moderate-to-vigorous physical activity (MVPA) measured continuously with a validated Fitbit tracker, with secondary outcomes including sedentary time and self-reported health-related quality of life. The intervention combines goal-setting, motivational content delivered by mobile/social media, and remote coaching components tailored to language and cultural preferences.
Who should consider this trial
Good fit: Ideal candidates are Hispanic/Latino AYA childhood cancer survivors aged 15 to under 21 who are in first continuous remission, completed chemotherapy and/or radiation 3–36 months ago, prefer English or Spanish, and report under 420 minutes of moderate-to-vigorous physical activity per week.
Not a fit: Patients who already meet physical activity guidelines, are outside the 15–20 age range, are not in first remission, have excluded transplant procedures or medical limitations that prevent activity, or are not able to use mobile devices may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help participants increase moderate-to-vigorous physical activity, reduce sedentary time, and improve quality of life, potentially lowering long-term health risks.
How similar studies have performed: Wearable and mobile health programs have shown modest success increasing activity in other populations, but culturally-tailored remote interventions specifically for Latino AYA childhood cancer survivors are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mesa, Arizona and 76 other locations
- Banner Children's at Desert — Mesa, Arizona, United States (Recruiting)
- Phoenix Childrens Hospital — Phoenix, Arizona, United States (Recruiting)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
- Kaiser Permanente Downey Medical Center — Downey, California, United States (Recruiting)
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (Recruiting)
- Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States (Recruiting)
- Mattel Children's Hospital UCLA — Los Angeles, California, United States (Recruiting)
- Valley Children's Hospital — Madera, California, United States (Recruiting)
- UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (Recruiting)
- Kaiser Permanente-Oakland — Oakland, California, United States (Recruiting)
- Rady Children's Hospital - San Diego — San Diego, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (Recruiting)
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (Recruiting)
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (Recruiting)
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (Recruiting)
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (Recruiting)
- Miami Cancer Institute — Miami, Florida, United States (Recruiting)
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Arnold Palmer Hospital for Children — Orlando, Florida, United States (Recruiting)
- Nemours Children's Hospital — Orlando, Florida, United States (Recruiting)
- Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (Recruiting)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
- Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States (Recruiting)
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States (Recruiting)
- Memorial Health University Medical Center — Savannah, Georgia, United States (Recruiting)
- Lurie Children's Hospital-Chicago — Chicago, Illinois, United States (Recruiting)
- University of Illinois — Chicago, Illinois, United States (Recruiting)
- Southern Illinois University School of Medicine — Springfield, Illinois, United States (Recruiting)
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
- Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States (Recruiting)
- Blank Children's Hospital — Des Moines, Iowa, United States (Recruiting)
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States (Recruiting)
- Children's Hospital New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States (Recruiting)
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (Recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
- Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States (Recruiting)
- Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University Medical Center of Southern Nevada — Las Vegas, Nevada, United States (Recruiting)
- Sunrise Hospital and Medical Center — Las Vegas, Nevada, United States (Recruiting)
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation — Las Vegas, Nevada, United States (Recruiting)
- Summerlin Hospital Medical Center — Las Vegas, Nevada, United States (Recruiting)
- Renown Regional Medical Center — Reno, Nevada, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Saint Peter's University Hospital — New Brunswick, New Jersey, United States (Recruiting)
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (Recruiting)
+27 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Jason A Mendoza — Children's Oncology Group
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.