Rural Adult and Youth Sun Protection Study

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Rural Adult and Youth Sun Protection Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 7 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06439979
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Utah
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yelena P Wu, PhD
Principal Investigator Affiliation	University of Utah
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma (Skin), Skin Cancer

Additional Details

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.

Arms & Interventions

Arms

Experimental: RAYS Intervention

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

No Intervention: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Site Contact

Yelena P Wu, PhD

[email protected]

801-585-0303

West Virginia University, Morgantown, West Virginia

Status