Contemporary clinical trials · 2026
The Rural Adult and Youth Skin protection study (RAYS): Protocol for a sun protection intervention trial in rural Utah and West Virginia sports programs.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wu Yelena P, Chipman Jonathan, Boatman Dannell, Welch Kate, Sleiman Marcelo M, Moyano Juliana, Jarrett Zack, Statman Muriel R, Braun Emma, Balls Nathan, Grossman Douglas, Abildso Christiaan G, Dzewaltowski David, VoPham Trang, Schlechter Chelsey, Wetter David W, Tercyak Kenneth P
Аннотация
BACKGROUND: Children in rural and underserved communities face a higher risk of developing skin cancer later in life owing to social, behavioral, and environmental factors. The goal of the Rural Adult and Youth Sun Protection (RAYS) trial is to evaluate the efficacy of a multicomponent, multilevel sun-safety intervention in improving sun protection among children in these communities.
METHODS: The RAYS cluster-randomized trial will test a sun safety intervention delivered through youth (ages 3-6) recreational sports settings in West Virginia and Utah and examine outcomes up to one year after enrollment. Enrolled sports leagues will be randomized to receive either RAYS, which targets sun safety-related adaptations at the individual, social, environmental, and policy levels, or an intervention that focuses on sports safety (no sun safety information). The primary outcome will be observed sun safety behaviors during sports practices and games; secondary outcomes will include parent-reported child sun protection and sunburn occurrence. Potential mediators (e.g., coach and parent knowledge and self-efficacy around skin cancer prevention) and factors related to trial outcomes, such as intervention fidelity and uptake and potential moderators (e.g., Area Deprivation Index), will also be examined.
CONCLUSIONS: The RAYS trial will examine the efficacy of a sports safety-focused intervention targeting sun protection behaviors among children in rural and underserved communities. The project will lead to new scientific understanding of theoretical, interventional, and implementation components that influence study outcomes and sociodemographic moderators, which will inform future intervention implementation in similar settings and identify communities which could best be served by RAYS.
CLINICAL TRIAL REGISTRATION: NCT06439979.
METHODS: The RAYS cluster-randomized trial will test a sun safety intervention delivered through youth (ages 3-6) recreational sports settings in West Virginia and Utah and examine outcomes up to one year after enrollment. Enrolled sports leagues will be randomized to receive either RAYS, which targets sun safety-related adaptations at the individual, social, environmental, and policy levels, or an intervention that focuses on sports safety (no sun safety information). The primary outcome will be observed sun safety behaviors during sports practices and games; secondary outcomes will include parent-reported child sun protection and sunburn occurrence. Potential mediators (e.g., coach and parent knowledge and self-efficacy around skin cancer prevention) and factors related to trial outcomes, such as intervention fidelity and uptake and potential moderators (e.g., Area Deprivation Index), will also be examined.
CONCLUSIONS: The RAYS trial will examine the efficacy of a sports safety-focused intervention targeting sun protection behaviors among children in rural and underserved communities. The project will lead to new scientific understanding of theoretical, interventional, and implementation components that influence study outcomes and sociodemographic moderators, which will inform future intervention implementation in similar settings and identify communities which could best be served by RAYS.
CLINICAL TRIAL REGISTRATION: NCT06439979.