Melanoma (Skin)RAYSNCT06439979
Rural Adult and Youth Sun Protection Study
A study testing RAYS Intervention in people with Melanoma (Skin) and Skin Cancer, run by University of Utah at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Skin Cancer
- What is being tested?
- RAYS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2024to Apr 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
West Virginia University
Morgantown, West Virginia, 26501
Dannell Boatman, EdD, 304-293-8409, dboatman@hsc.wvu.edu
Zack Jarrett, MS, 304-293-8409, rays-wv@hsc.wvu.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Yelena P Wu, PhD, 8015850303, yelena.wu@utah.edu
Kate M Welch, BS, 8015850303, kate.welch@hci.utah.edu
About this study
Official title: Rural Adult and Youth Sun Protection Study - Rural Baseball R01
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.
Read the 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.
- Conditions
- Melanoma (Skin), Skin Cancer
- Being tested
- RAYS Intervention
- Keywords
- Rural, Melanoma, Skin cancer, Prevention, Underserved communities, Youth, Sports
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAYS InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Secondary outcomes (2)
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").
Measured: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
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.
Measured: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start8 Apr 2024
- Primary completionAug 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 843 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, West Virginia University
- Responsible party
- Principal investigator, Yelena Wu, University of Utah
- Investigators
- Yelena P Wu, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439979
- Sponsor's protocol ID
- 00173007
- Acronym
- RAYS
- Status last verified
- Aug 2026
- First submitted
- 13 May 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu YP, Chipman J, Boatman D, Welch K, Sleiman MM Jr, Moyano J, Jarrett Z, Statman MR, Braun E, Balls N, Grossman D, Abildso CG, Dzewaltowski D, VoPham T, Schlechter C, Wetter DW, Tercyak KP. The Rural Adult and Youth Skin protection study (RAYS): Protocol for a sun protection intervention trial in rural Utah and West Virginia sports programs. Contemp Clin Trials. 2026 Jul 31:108417. doi: 10.1016/j.cct.2026.108417. Online ahead of print.
PubMed 42537926