Rural Adult and Youth Sun Protection Study

Melanoma (Skin) Clinical Trial

— RAYS  

Official title:

Rural Adult and Youth Sun Protection Study - Rural Baseball R01

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439979
• Other study ID #: 00173007
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: April 2030

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Yelena P Wu, PhD
• Phone: 8015850303
• Email: yelena.wu[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 843
• Est. completion date: April 2030
• Est. primary completion date: August 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Skin Cancer
• Skin Neoplasms

Intervention

Behavioral:
• RAYS Intervention
Developmental baseball leagues will be randomly assigned to RAYS vs. control. Outcomes include directly-observed child sun safety behaviors after controlling for environmental ultra-violet radiation (UVR), with parent-reported child sun protection and other related endpoints at 1 year.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Georgetown University, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Directly observed child sunscreen application	Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who applied sunscreen at any time during the practice or game. This tallied number will create a percentage of the team that applied sunscreen. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.; "How many wearing sunscreen?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.	At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Primary	Directly observed child hat wearing	Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a hat at any time during the practice or game. This tallied number will create a percentage of the team that wore a hat. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.; "How many wore a hat?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.	At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Primary	Directly observed child wearing long sleeves	Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a long-sleeved shirt at any time during the practice or game. This tallied number will create a percentage of the team that wore protective long-sleeved shirts. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.; "How many wore long sleeves?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.	At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Primary	Directly observed child shade seeking	Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who spent time in shade or under an umbrella at any time during the practice or game. This tallied number will create a percentage of the team that spent time in shade/under umbrella. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.; "How many in shade/under umbrella?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.	At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Secondary	Parent-reported child sun protection behaviors	A random sample of parents will report on their child's use of sun protection using the Sun Habits Survey, a well-established and valid measure. These same parents will be asked to complete questionnaires at baseline, end-of-season, and at 1 year follow-up.; "On a warm and sunny day, how often did your child...Use sunscreen with a sun protective factor (SPF) of 30+?" All parent-reported items will be assessed on a 5-point Likert-type scale ("Never" to "Always").	At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Secondary	Parent-report child sunburn	Parents will report on the number of sunburns their child experienced during baseball and not during baseball at baseline, post-intervention and one-year post-baseline. Parents will report on child behaviors using items from the Sun Habits Survey.; "How many times did your child have a red OR painful sunburn that lasted a day or more? In the past month? In the past 12 months?" Minimum value = 0, maximum value = 5 or more.; A low number indicates a better outcome.	At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline