Enrollment on hold
Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
NCT No.: NCT06410209
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym:
Official Title
Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
Purpose
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.
Detailed Description
Eligibility 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: 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
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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
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Keywords and/or Specific Medical Conditions
Sponsors
- Children's Oncology Group
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