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A Personalized Approach to Skin Cancer Prevention Among Adolescents
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.
Enrollment: Recruitment will occur through schools and districts that are committed to partnering with the study team. Schools will be stratified into 2 groups and then randomized to receive either the SHINE intervention or standard education. Stratification will be based on school demographic factors. The investigators anticipate enrolling a total of 30 schools into the trial, with approximately half of schools assigned to the SHINE intervention. Prior to student enrollment, parents will be sent a cover letter describing the study and will be given the choice of opting their child out of the study. Students will receive an assent cover letter and will be given the choice of opting out of the study. With the exception of students who opt out of participation or are opted out by their parents, all students between the ages of 11 and 21 years present in class during the days of intervention delivery and assessments will receive the intervention and be asked to complete the assessments. Intervention: After randomization, each school will receive the intervention materials for the condition to which they were assigned. Both SHINE and standard education groups will receive 2 in-class intervention sessions, each lasting 40 minutes each, and a 40-minute in-class booster sessions. Schools allocated to SHINE will create individualized action plans and receive personalized UV photos. Schools allocated to standard education will receive presentations of basic skin cancer prevention information available through the American Academy of Dermatology and Centers for Disease Control and Prevention. Study Assessments: Regardless of which intervention group students are randomized to, they will be asked to complete 5 assessments. The first assessment (baseline) will occur in the fall. The intervention will be delivered in the spring. Approximately one month post-intervention, students will be asked to complete the first post-intervention assessment, followed by a summer assessment delivered 3-4 months post-intervention. Students will also be asked to complete two longer-term follow-up assessments at one year post-baseline and one-year post-intervention. All assessments will be completed via the web using REDCap. Each of these assessments is expected to take no more than 20 minutes. Students will be asked to provide information via questionnaire on sun protection behaviors, tanning behaviors, sunburn occurrence, self-efficacy and response efficacy related to skin cancer, susceptibility to skin cancer, severity of skin cancer, demographic characteristics, recall of the intervention, and knowledge and awareness of skin cancer prevention and risk.
Age
11 - 21 years
Sex
ALL
Healthy Volunteers
Yes
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Start Date
September 14, 2020
Primary Completion Date
July 15, 2025
Completion Date
July 15, 2025
Last Updated
October 14, 2025
2,223
ACTUAL participants
SHINE Intervention
BEHAVIORAL
Lead Sponsor
University of Utah
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04036331