Grant Number:	5R01CA274450-03 Interpret this number
Primary Investigator:	Mendoza, Jason
Organization:	Seattle Children'S Hospital
Project Title:	Developing and Testing a Culturally Tailored Mobile Health and Social Mediaphysical Activity Intervention Among Adolescent and Young Adult Childhoodcancer Survivors
Fiscal Year:	2025

Childhood cancer survivors with Spanish ancestry, customs, and/or traditions (henceforth termed ancestry) have an increased risk of cardiometabolic dysfunction. While physical activity (PA) is associated with lower risk of cancer recurrence, cardiometabolic dysfunction, and higher quality of life, 57% of survivors with Spanish ancestry are inactive. Specially designed interventions to increase PA for AYA survivors with Spanish ancestry do not currently exist despite their urgent need. We will address this critical gap by efficiently leveraging the infrastructure in the Children’s Oncology Group (COG) created by our ongoing StepByStep randomized controlled trial (RCT; U01CA246665) that investigates a general mHealth PA intervention in AYA childhood cancer survivors among English-speakers. We have been successful in enrolling patients from COG, conducting assessments and intervention components remotely. Because the U01 StepByStep RCT is limited to the general population of English speakers, we propose (1) to apply a special design process for behavioral interventions, using the general StepByStep intervention as a starting point, to create a novel intervention for survivors with Spanish ancestry and (2) to test the resulting intervention in a short term efficacy RCT. We will efficiently extend the study infrastructure within COG to recruit survivors with Spanish ancestry who speak Spanish and/or English. In response to PAR-21-190 (Modular R01), we propose the following Specific Aims: 1. Use an iterative approach to develop a novel, specially designed multilevel remote-based PA intervention among 20 AYA childhood cancer survivors with Spanish ancestry whose preferred language is Spanish or English. The iterative process will combine 3 rounds of testing of the intervention components alternating with qualitative interviews to obtain participant feedback to guide intervention modifications. 2. Conduct a RCT to test the efficacy of the specially designed remote-based PA intervention over 12 weeks among a separate group of 160 AYA childhood cancer survivors with Spanish ancestry whose preferred language is Spanish or English (n=80 per randomization arm) and who do not meet PA guidelines. The control group will receive a Fitbit only. We will test the following hypotheses (H): H1: Intervention participants will have greater increases in moderate-to-vigorous PA (primary outcome) than controls as assessed by accelerometry. H2. Intervention participants will have greater improvements in cardiopulmonary fitness and resting heart rate than controls as assessed by the 2-minute step test and heart rate monitor (exploratory outcomes). H3: Intervention participants will have greater improvements in global, physical, and social functioning and fatigue than controls as assessed by validated self-report instruments (exploratory outcomes). Conduct two rounds of post-trial qualitative interviews, n=30 for the intensive intervention phase and n=30 for the maintenance intervention phase, to make improvements in preparation for a fully powered RCT.





None