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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Adult and Youth Sun Protection Study - Rural Baseball R01
- ClinicalTrials.gov ID
- NCT06439979
- Acronym / sponsor ID
- RAYS / 00173007
- Conditions
- Melanoma (Skin), Skin Cancer
- Keywords
- Rural, Melanoma, Skin cancer, Prevention, Underserved communities, Youth, Sports
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 843 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Georgetown University, West Virginia University
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RAYS Intervention | Experimental | Behavioral: RAYS InterventionThe RAYS arm is the intervention being tested, which will include skin cancer prevention education and providing participants with sun-safety supplies. |
| 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAYS InterventionDevelopmental 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. | Behavioural | RAYS Intervention |
Primary outcome
Directly observed child sunscreen application
Time frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
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.
Directly observed child hat wearing
Time frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
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.
Directly observed child wearing long sleeves
Time frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
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.
Directly observed child shade seeking
Time frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)
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.
2 secondary outcomes
Parent-reported child sun protection behaviors
Time frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Parent-report child sunburn
Time frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 42537926Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yelena P Wu, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAYS Intervention in people with Melanoma (Skin) and Skin Cancer, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yelena P Wu, PhD (8015850303, yelena.wu@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Directly observed child sunscreen application (time frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.