Sun-Safe Habits Education for Skin Cancer Prevention in Adolescents

(SHINE Trial)

Overseen By Jacey Jones, BS

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Developmental delay

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the SHINE (Sun-safe Habits Intervention and Education) program can help high school students in Utah better protect their skin from the sun and reduce intentional tanning. Schools will be divided into two groups: one will implement the SHINE program, which includes personalized sun safety plans, while the other will receive standard skin cancer education. This trial suits high schoolers in Utah interested in learning more about protecting their skin from sun damage. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially impactful sun safety program.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the SHINE intervention is safe for adolescents?

Research has shown that the SHINE program teaches sun-safe habits to help prevent skin cancer, including education on sun protection and reducing tanning in teens. As an educational program, not a drug or medical procedure, it poses no known physical safety risks like those associated with medications.

Previous studies have not reported any negative effects from the SHINE program. As a Phase 3 trial, earlier research likely demonstrated its safety. Participants can feel confident about the safety of this educational approach while learning how to protect their skin. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHINE Intervention because it offers a personalized approach to skin cancer prevention, particularly among adolescents. Unlike standard education programs that provide general information, SHINE tailors its content to each participant by assessing their unique UV exposure and skin cancer risk. This individualized sun protection action plan aims to engage teens more effectively by making the information relevant to their personal habits and risks, potentially leading to better long-term sun-safe habits and reduced skin cancer rates.

What evidence suggests that the SHINE intervention is effective for skin cancer prevention in adolescents?

Research has shown that programs like SHINE, which participants in this trial may receive, can help teenagers better protect themselves from the sun. In past studies, individuals who received personalized advice on preventing skin cancer made more positive changes in their habits. They used sun protection more frequently than those who only received general information. In this trial, the SHINE program offers personalized tips and a plan to reduce sun exposure and lower the risk of skin cancer. These tools aim to help students develop better sun safety habits. ^{1 2 4 6 7}

Who Is on the Research Team?

Yelena Wu, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for high school students in Utah, grades 9-12. It's designed to test if a program called SHINE can help them use sun protection and avoid intentional tanning. Students who don't speak English or have developmental delays that prevent participation are not eligible.

Inclusion Criteria

Students are eligible for this trial if they attend high school in Utah (e.g. are enrolled in grades 9-12).

Exclusion Criteria

I do not have a developmental delay that prevents participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Schools receive two in-class intervention sessions and a booster session, focusing on sun protection and skin cancer prevention.

Spring semester

3 in-class sessions

Follow-up

Participants are monitored for changes in sun protection behaviors and tanning habits through assessments.

56 weeks

5 assessments via web

Long-term Follow-up

Participants complete additional assessments to evaluate long-term behavior changes.

1 year post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• SHINE Intervention

Trial Overview The SHINE intervention involves two in-class sessions aimed at improving sun-safe habits among adolescents. The study will compare the results of schools receiving SHINE with those getting standard education on skin cancer prevention.

How Is the Trial Designed?

Group I: SHINE Experimental Treatment 1 Intervention

Participants will be randomized to receive an intervention that provides information on skin cancer and preventive strategies, features a personalized skin cancer prevention packet that focuses on students' UVR exposure and skin cancer risk, and includes the creation of a individualized sun protection action plan.

Group II: Standard Education Active Control 1 Intervention

Participants will be randomized to receive information that covers general skin cancer education for pediatric populations.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Multicomponent curricula delivered over extended periods are the most effective interventions for teaching children about skin cancer prevention, with younger children being more receptive to these programs than older children.

Interventions in Australia have shown greater success compared to those in North America and Europe, highlighting the need for further research to address gaps in educational strategies and to test the effectiveness of specific components in changing children's attitudes towards sun protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention of skin cancer in children and adolescents: a review of the literature. Hart, KM., Demarco, RF.[2008]

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]

A systematic review of 10 studies involving various intervention types found that most behavioral interventions effectively increased awareness and knowledge about skin cancer among U.S. adolescents.

Despite improved knowledge about skin cancer risks, this awareness did not translate into a significant increase in self-reported sun-protection behaviors, highlighting a gap between knowledge and action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational interventions to promote sun-protection behaviors in adolescents in the United States: A systematic review. Tran, T., Song, S., Texeira, AJ., et al.[2023]

School-based interventions significantly improved sun protection behaviors and sun-safe knowledge among elementary and secondary school students, as shown in a systematic review of 65 studies.

While many studies reported positive changes in attitudes towards tanning and some reduction in sunburns and nevus counts, most studies had a high risk of bias, indicating the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based interventions to improve sun-safe knowledge, attitudes and behaviors in childhood and adolescence: A systematic review. Reyes-Marcelino, G., Wang, R., Gultekin, S., et al.[2021]

An intensive intervention program significantly improved solar protection behaviors among 247 students aged 9 to 11, showing higher usage of sun protection compared to control and standard intervention groups at both 4 weeks and 8 months post-intervention.

The study found that prior levels of solar protection were strong predictors of future protective behavior, while increased opportunities for protection were associated with decreased protective behavior over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of interventions to improve solar protection in primary schools. Girgis, A., Sanson-Fisher, RW., Tripodi, DA., et al.[2019]

A 12-week SMS-based intervention significantly improved sun safety behaviors and knowledge among 96 middle school students, including increased sunscreen use and sun avoidance during peak UV times.

Participants reported high satisfaction with the program, and 15% shared the sun safety messages with others, indicating potential for broader community impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a short messaging service-based skin cancer prevention campaign in adolescents. Hingle, MD., Snyder, AL., McKenzie, NE., et al.[2021]

A school-based intervention targeting approximately 400 adolescents in Queensland, Australia, aims to improve sun protective behaviors through three one-hour sessions focusing on attitudes, normative support, and self-efficacy over three weeks.

The study will assess the effectiveness of the intervention by measuring changes in intentions and actual sun protection behaviors, providing insights into how to better encourage sun safety among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of a theory-based intervention to improve sun protective behaviour in adolescents ('you can still be HOT in the shade'): study protocol. Hawkes, AL., Hamilton, K., White, KM., et al.[2022]

The 'Live Sun Smart!' program effectively improved sun safety knowledge and attitudes toward tanning among middle school students, indicating its potential as a valuable educational tool.

While the program did not significantly change self-reported sun safety behaviors, students expressed a willingness to alter their behaviors, suggesting that the intervention may influence future sun protection practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Live Sun Smart!" Testing the effectiveness of a sun safety program for middle schoolers. Steele, C., Burkhart, C., Tolleson-Rinehart, S.[2021]

80% of a person's lifetime sun exposure happens before they turn 18, making it crucial to educate both parents and adolescents about sun safety to prevent skin cancers.

Educational interventions should focus on promoting sun-protective behaviors such as using sunscreen, wearing protective clothing, and seeking shade, with school nurses playing a key role in implementing these health education strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging sun safety for children and adolescents. Boe, K., Tillotson, EA.[2017]

A 1-day school-based program called Sun Smart Day effectively increased fourth-graders' knowledge and awareness of skin cancer prevention, with benefits lasting through the summer break.

Both the classroom lesson and the interactive health fair improved sun safety awareness, but the classroom approach was easier to implement, while the health fair was more engaging for students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sun Smart Day: a pilot program for photoprotection education. Buller, MK., Goldberg, G., Buller, DB.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04341064

Sun-safe Habits Intervention and Education (SHINE) The purpose of this study is to determine the efficacy of the Sun-safe Habits Intervention and Education (SHINE) intervention in improving sun protection ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11065585/

Protocol for a Cluster-Randomized Trial of a School-Based ... Arm 1 of the trial will be the SHINE intervention, which is a personalized skin cancer prevention intervention that aims to increase adolescents' sun protection ...

3. withpower.com withpower.com/trial/phase-3-skin-neoplasms-8-2020-2c845

Sun-Safe Habits Education for Skin Cancer Prevention in ... The purpose of this study is to determine the efficacy of the Sun-safe Habits Intervention and Education (SHINE) intervention in improving sun protection ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3815976/

Randomized Trial of Tailored Skin Cancer Prevention for ... Tailored group participants demonstrated significantly greater positive changes in prevention behavior after the intervention, including children's use of ...

5. uofuhealth.utah.edu uofuhealth.utah.edu/huntsman/labs/wu/research

Wu Team Research The goal of the SHINE study, funded by the National Cancer Institute, is to promote school-based efforts focused on skin cancer prevention. We are testing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000685

Protocol for a cluster-randomized trial of a school-based ... This trial examines the efficacy of a personalized intervention targeting sun protection and tanning of high school students.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07930

Personalized Skin Cancer Education Program for the ... This phase III trial compares a personalized skin cancer prevention program, sun-safe habits intervention and education (SHINE), to standard skin cancer ...