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

Recruiting now · Phase 2

Conditions studied: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT06410209

Run by

Children's Oncology Group

People needed

190

Starts

2024-10-15

Expected to finish

2027-09-15

Last updated by the study team

2026-02-27

Who can join

Age: 15 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Kaiser Permanente Downey Medical Center — Downey, California, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States (enrolling)
• Mattel Children's Hospital UCLA — Los Angeles, California, United States (enrolling)
• Valley Children's Hospital — Madera, California, United States (enrolling)
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
• Rady Children's Hospital - San Diego — San Diego, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (enrolling)
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Miami Cancer Institute — Miami, Florida, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
• Nemours Children's Hospital — Orlando, Florida, United States (enrolling)
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Banner Children's at Desert — Mesa, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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