10250 Participants Needed

Sun-Safe Habits Education for Skin Cancer Prevention in Adolescents

(SHINE Trial)

AP
NS
SD
JJ
Overseen ByJacey Jones, BS
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Utah
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the effectiveness of the SHINE treatment for skin cancer prevention in adolescents?

Research shows that educational interventions can increase awareness and knowledge about skin cancer risks and sun protection among adolescents, although this does not always lead to changes in behavior. Multicomponent programs over time have been more effective, especially in younger children, suggesting that the SHINE treatment could be beneficial if it includes multiple educational components and is sustained over a period.12345

Is the Sun-Safe Habits Education intervention safe for adolescents?

The studies reviewed focus on improving sun protection behaviors and knowledge among adolescents, and none reported any safety concerns related to the interventions. These educational programs are generally considered safe for use in school settings.12678

How is the SHINE Intervention treatment different from other treatments for skin cancer prevention in adolescents?

The SHINE Intervention is unique because it focuses on educating adolescents about sun-safe habits through behavioral counseling, which is shown to be effective in increasing sun-protective behaviors and reducing UV exposure. Unlike other treatments that may focus on medical or topical solutions, this intervention targets behavior change in schools to establish lifelong sun safety habits.167910

What is the purpose of this trial?

The purpose of this study is to determine the efficacy of the Sun-safe Habits Intervention and Education (SHINE) intervention in improving sun protection use and decreasing intentional tanning among high school students. It's anticipated that 30 schools will be randomized into the trial, with approximately half assigned to SHINE and the other half assigned to standard education. After randomization and a baseline assessment, each school will receive two in-class intervention sessions delivered by an interventionist. Follow-up assessments will be completed one month post-intervention, 3-4 months post-intervention, one year post-baseline, and one year post-intervention.

Research Team

YW

Yelena Wu, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: SHINEExperimental Treatment1 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 EducationActive Control1 Intervention
Participants will be randomized to receive information that covers general skin cancer education for pediatric populations.

Find a Clinic Near You

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+

Findings from Research

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

References

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. [2022]
Educational interventions to promote sun-protection behaviors in adolescents in the United States: A systematic review. [2023]
Primary prevention of skin cancer in children and adolescents: a review of the literature. [2008]
Planning for a brighter future: a review of sun protection and barriers to behavioral change in children and adolescents. [2021]
Sun Smart Day: a pilot program for photoprotection education. [2019]
"Live Sun Smart!" Testing the effectiveness of a sun safety program for middle schoolers. [2021]
Evaluation of interventions to improve solar protection in primary schools. [2019]
School-based interventions to improve sun-safe knowledge, attitudes and behaviors in childhood and adolescence: A systematic review. [2021]
Encouraging sun safety for children and adolescents. [2017]
Effects of a short messaging service-based skin cancer prevention campaign in adolescents. [2021]
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