Sun-safe Habits Intervention and Education (SHINE)

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 3

Conditions: Adolescents; Skin Cancer

Treatments: Behavioral: SHINE Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04341064

1R01CA244674-01 (U.S. NIH Grant/Contract)

IRB_00118620

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,223 patients

Sex: All

Ages: 11 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Students will be excluded from participation if they:

• Do not speak English.
• Are unable to participant due to a developmental delay.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,223 participants in 2 patient groups

SHINE

Experimental group

Description:

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.

Treatment:

Behavioral: SHINE Intervention

Standard Education

No Intervention group

Description:

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