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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

RECRUITINGPhase 2Sponsored by Children's Oncology Group
Actively Recruiting
PhasePhase 2
SponsorChildren's Oncology Group
Started2024-10-15
Est. completion2027-09-15
Eligibility
Age15 Years – 20 Years
Healthy vol.Accepted
Locations76 sites

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.

Eligibility

Age: 15 Years – 20 YearsHealthy volunteers 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

Conditions3

CancerHematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Locations76 sites

Banner Children's at Desert
Mesa, Arizona, 85202
Site Public Contact480-412-3100
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Public Contact602-546-0920
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Site Public Contact501-364-7373
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Site Public Contact626-564-3455
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact800-826-4673becomingapatient@coh.org

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