Rural Adult and Youth Sun Protection Study

NCT ID: NCT06439979

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

843 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2030-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma (Skin) Skin Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Rural Melanoma, Skin cancer Prevention Underserved communities Youth Sports

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Masking will only be used for participants in the study. Investigators will know which arm of the study each participant has been randomized to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RAYS Intervention

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

Group Type EXPERIMENTAL

RAYS Intervention

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


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.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Georgetown University

OTHER

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yelena Wu

Associate Professor, Department of Dermatology; Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yelena P Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yelena P Wu, PhD

Role: CONTACT

Phone: 8015850303

Email: [email protected]

Kate M Welch, BS

Role: CONTACT

Phone: 8015850303

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yelena P Wu, PhD

Role: primary

Kate M Welch, BS

Role: backup

Dannell Boatman, EdD

Role: primary

Zack Jarrett, MS

Role: backup

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form: ICF_Utah_Coaches

View Document

Document Type: Informed Consent Form: ICF_Utah_Parents

View Document

Document Type: Informed Consent Form: ICF_Utah_CommunityMembers

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00173007

Identifier Type: -

Identifier Source: org_study_id