Rural Adult and Youth Sun Protection Study

NCT06439979 | Recruiting DMC

• 1 other identifier: 00173007
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma (Skin); Skin Cancer

Keywords

Rural; Melanoma, Skin cancer; Prevention; Underserved communities; Youth; Sports

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Parent-reported child sun protection behaviors

  At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline

• Parent-report child sunburn

  At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline

Study Arms (2)

RAYS Intervention

EXPERIMENTAL

The RAYS arm is the intervention being tested, which will include skin cancer prevention education and providing participants with sun-safety supplies.

Behavioral: RAYS Intervention

Control

NO INTERVENTION

The Control arm of the study will not receive any skin cancer prevention information or sun-safety materials but will only receive general injury prevention information.

Interventions

RAYS Intervention BEHAVIORAL

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.

RAYS Intervention

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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)
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Georgetown University: collaborator
• West Virginia University: collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26501, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yelena P Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yelena P Wu, PhD

CONTACT

8015850303; yelena.wu@utah.edu

Kate M Welch, BS

CONTACT

8015850303; kate.welch@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking will only be used for participants in the study. Investigators will know which arm of the study each participant has been randomized to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Dermatology; Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 3, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)