Clinical trial NCT06439979: Rural Adult and Youth Sun Protection Study
Official title: Rural Adult and Youth Sun Protection Study - Rural Baseball R01
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Skin Cancer
Keywords: Rural
Melanoma, Skin cancer
Prevention
Underserved communities
Youth
Sports
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: West Virginia University
First posted: 2024-06-03
Enrollment: 843
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RAYS uses a 2-arm cluster-randomized trial in 2 rural US states (Utah and West Virginia) matched for high skin cancer burden and rurality. This parallel model includes an intervention arm, which will include sun-safety education and skin cancer prevention, and the control arm which will focus on general sports-related injury prevention. Leagues enrolled in the study will be randomized to one of the two arms.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia.

Detailed description: Children living in rural and under-served communities are at high risk for skin cancer; however, there are no evidence-based sun safety interventions showing durable effects for this vulnerable pediatric population. The objective of this proposal is to rigorously test a novel, multi-level approach to skin cancer prevention among young rural children that is delivered through developmental baseball leagues. To attain this objective, the investigators will conduct a two-arm cluster-randomized trial with the primary outcome being multi-behavior sun protection change among children.

Eligibility criteria: Parent inclusion criteria:

i. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

ii. Live and/or work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems)

Coach/leader inclusion criteria:

i. Adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older

ii. Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

Participant inclusion criteria for minor participants (ages 3 and older) are as follows:

i. Live in rural communities and/or participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).

Participant inclusion criteria for key informant interviews are as follows:

i. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and/or adults who currently have minor children 3 years of age or older playing on participating sports teams and/or adults who live and/or work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)

Local sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball/softball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older.

Exclusion Criteria:

* Adults and children who do not speak or read English will be excluded.
* For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.

Primary outcomes:
measure: Directly observed child sunscreen application
timeFrame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
measure: Directly observed child hat wearing
timeFrame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
measure: Directly observed child wearing long sleeves
timeFrame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
measure: Directly observed child shade seeking
timeFrame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Secondary outcomes:
measure: Parent-reported child sun protection behaviors
timeFrame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
measure: Parent-report child sunburn
timeFrame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Utah
name: Yelena P Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: