Sun Protection for Skin Cancer Prevention

(RAYS Trial)

Recruiting at 1 trial location

Overseen By Kate M Welch, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

843 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent skin cancer by promoting better sun protection habits among young people in rural Utah and West Virginia. Participants will receive education on skin cancer prevention and sun-safety supplies through the RAYS intervention (Rural Adult and Youth Sun Protection Study Intervention), while a control group will receive only general injury prevention information. The trial seeks parents with children aged 3 and older in rural sports leagues, as well as coaches and leaders in these communities. Those living or working in these areas with children in sports may find this trial a good fit. As an unphased trial, this study offers a unique opportunity to contribute to community health and improve sun safety practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the RAYS Intervention is safe for youths?

Research has shown that the RAYS Intervention is safe for participants. This program educates people on preventing skin cancer and provides sun-safety supplies. No reports have indicated any problems or safety issues with this type of program. The goal is to help people change their habits, not to test a new drug or medical procedure, making it very low-risk. Participants in similar studies have handled the program well, experiencing no harmful effects. This suggests that the RAYS program is a safe way to improve sun protection habits and possibly prevent skin cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RAYS Intervention for skin cancer prevention because it takes a proactive approach by combining education with tangible tools, like sun-safety supplies, to encourage better sun protection habits. Unlike typical methods that only offer general advice or leave individuals to source their own protective gear, this intervention provides both knowledge and resources directly to participants. This dual approach aims to make sun protection more accessible and effective, potentially reducing skin cancer risk more efficiently than current options.

What evidence suggests that the RAYS Intervention is effective for skin cancer prevention?

The RAYS Intervention, available to participants in this trial, helps young people enhance their sun safety habits, such as wearing hats, using sunscreen, and staying in the shade. By promoting these practices, RAYS aims to reduce the risk of skin cancer, particularly in rural areas. Early research indicates that participants in similar programs are more likely to adopt these protective habits. This suggests that RAYS could effectively prevent skin cancer over time. ^{1 2 3 4 6}

Who Is on the Research Team?

Yelena P Wu, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for youths and adults in rural Utah or West Virginia who are involved with local sports leagues. Eligible participants include parents of children aged 3+, coaches, and leaders of youth sports teams. People must be able to speak and read English, without medical conditions that prevent survey completion.

Inclusion Criteria

Parent inclusion criteria: 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: Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

I am a minor living in or participating in sports in a rural area of Utah or West Virginia.

Exclusion Criteria

I can speak and read English.

Individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of surveys will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

RAYS intervention includes skin cancer prevention education and providing sun-safety supplies

6 weeks

2 visits (in-person)

Post-intervention Assessment

Observation of sun protection behaviors such as sunscreen application, hat wearing, and shade seeking

3-6 weeks

Follow-up

Participants are monitored for sun protection behaviors and sunburn incidence

1 year

What Are the Treatments Tested in This Trial?

Interventions

• RAYS Intervention

Trial Overview The RAYS Intervention is being tested to see if it can improve sun protective behaviors among rural community members in an effort to prevent skin cancer. The study focuses on educating those involved with youth sports leagues.

How Is the Trial Designed?

Group I: RAYS Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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 Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Published Research Related to This Trial

The UV4.me Internet intervention significantly reduced UV exposure and increased skin protection behaviors among young adults aged 18-25, with notable improvements observed at both 3 and 12 weeks after the intervention compared to a control group.

This study is the first randomized controlled trial demonstrating the effectiveness of an online program in modifying skin cancer risk behaviors, highlighting its potential as a scalable public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Heckman, CJ., Darlow, SD., Ritterband, LM., et al.[2018]

A scoping review of 12 studies focused on rural outdoor workers aged 50 and older revealed that these individuals face unique skin cancer risks due to prolonged UV radiation exposure, particularly in rural areas.

The review highlights the need for tailored prevention strategies and improved access to sun protection resources to address the specific challenges faced by this high-risk population, emphasizing the importance of targeted public health policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and early prevention of skin cancer in rural older outdoor workers: A scoping review. Yu, SY., Hirsch, A., Zaslavsky, O., et al.[2023]

Education and policy approaches aimed at increasing sun-protective behaviors have been effective in primary schools and recreational settings for reducing skin cancer risk, according to a systematic review by the Task Force on Community Preventive Services.

However, there is insufficient evidence to support the effectiveness of these interventions in other environments, such as child care centers and healthcare settings, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent skin cancer by reducing exposure to ultraviolet radiation: a systematic review. Saraiya, M., Glanz, K., Briss, PA., et al.[2022]

Despite increased awareness of the link between UV radiation and skin cancer, effective behavioral change regarding sun protection among youth remains slow, highlighting the need for improved intervention strategies.

The review identifies key barriers to sun protection practices in youth and emphasizes the importance of targeting specific age groups and utilizing role models to enhance the effectiveness of sun protection programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning for a brighter future: a review of sun protection and barriers to behavioral change in children and adolescents. Dadlani, C., Orlow, SJ.[2021]

High-risk sun-tanning behavior, which increases the risk of melanoma and non-melanoma skin cancer, is more prevalent among younger women, individuals with certain skin types, and those with higher incomes, according to a study of 18,685 Danes from 2008-2011.

The Danish Sun Safety Campaign, launched in 2007, successfully reduced high-risk tanning behaviors, particularly among women and younger individuals, suggesting it may help lower future skin cancer rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-risk sun-tanning behaviour: a quantitative study in Denmark, 2008-2011. Hansen, MR., Bentzen, J.[2018]

A study involving 100 beachgoers showed that a multicomponent intervention effectively increased sun protection behaviors and motivation to change, compared to a control group that only completed questionnaires.

The intervention successfully personalized the risks of skin cancer and educated participants about sun protection, leading to healthier behaviors without increasing sun exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multicomponent intervention on motivation and sun protection behaviors among midwestern beachgoers. Pagoto, S., McChargue, D., Fuqua, RW.[2022]

44% of US adolescents and their parents reported receiving sun protection counseling from physicians, which was more common among those with additional sources of information and family history of skin cancer.

Receiving physician counseling was linked to better sun protection behaviors, such as regular sunscreen use and proper application, highlighting the importance of healthcare providers in promoting skin cancer prevention among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician sun protection counseling: prevalence, correlates, and association with sun protection practices among US adolescents and their parents, 2004. Bandi, P., Cokkinides, VE., Weinstock, MA., et al.[2015]

Only 21% of the 32,440 adults surveyed in the 1998 National Health Interview Survey reported ever having a skin cancer examination, highlighting a significant gap in skin cancer screening participation.

Participation in sun-protective behaviors was low, with only 30% of respondents using sunscreen regularly, indicating a need for increased awareness and education on skin cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle high-risk behaviors and demographics may predict the level of participation in sun-protection behaviors and skin cancer primary prevention in the United States: results of the 1998 National Health Interview Survey. Santmyire, BR., Feldman, SR., Fleischer, AB.[2022]

A study of 573 schoolchildren in Montpellier revealed that many children spend over 6 hours outside daily during summer, highlighting a significant risk for excessive sun exposure.

Despite some protective behaviors, such as sunscreen use at the beach (70% of children), overall sun protection is inadequate, especially among adolescents, indicating a need for improved educational campaigns on sun safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sun exposure behavior of children between 3-15 years of age living in Montpellier]. Vergnes, C., Daures, JP., Sancho-Garnier, H., et al.[2015]

A study involving 58 adolescent and young adult cancer survivors found that using ultraviolet light photography (UVP) is an acceptable and non-distressing method to promote sun protection behaviors.

Follow-up data from 23 participants indicated that those who received UVP showed significant improvements in their sun protection practices compared to those who only received standard educational materials, suggesting UVP could be an effective tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Appearance-Based Messages to Increase Sun Protection in Adolescent Young Adult Cancer Survivors: A Pilot Study of Ultraviolet Light Photography. Recklitis, CJ., Bakan, J., Werchniak, AE., et al.[2018]

A study involving college students tested four different interventions to improve skin cancer prevention behaviors, finding that those who received both personalized UV photos and genetic testing showed the most significant positive changes in sun protection habits.

The research suggests that using multiple strategies for communicating skin cancer risks can effectively encourage healthier behaviors among young adults, particularly in a population that is at higher risk for skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Skin Cancer Prevention in Young Adults: the Cumulative Impact of Personalized UV Photography and MC1R Genetic Testing. Wu, YP., Hamilton, JG., Kaphingst, KA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06439979

NCT06439979 | Rural Adult and Youth Sun Protection Study 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 ...

2. cancer.wvumedicine.org cancer.wvumedicine.org/about-us/programs/rays/

Rural Adult and Youth Sun Protection (RAYS) The research team will learn if RAYS improves skin cancer prevention behaviors in childhood which may help to reduce skin cancer cases in rural areas over time.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11031317/

Preliminary Effects of a Rural Skin Cancer Prevention ... To pilot and assess the feasibility, acceptability and preliminary effects of the Rural Adult and Youth Sun Protection (RAYS) program, a multilevel skin cancer ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03312

Rural Adult and Youth Sun Protection Program to Improve ... This clinical trial tests the impact of the Rural Adult and Youth Sun (RAYS) protection program on sun protective behaviors in rural baseball leagues.

5. reporter.nih.gov reporter.nih.gov/search/TYyuoez0OUWufZdq8tAD-A/project-details/11078355

RePORT RePORTER - National Institutes of Health (NIH) | We will test a new skin cancer prevention program for young children living in these communities that is delivered through youth sports leagues. This project ...

6. careacross.com careacross.com/clinical-trials/trial/NCT06439979

Rural Adult and Youth Sun Protection Study 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 ...