Clinical trial NCT04341064: Sun-safe Habits Intervention and Education
Official title: A Personalized Approach to Skin Cancer Prevention Among Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Skin Cancer
Adolescents
Keywords: Education
Prevention and Control
Behavioral Research
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-10
Enrollment: 10250
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Sunscreen Re-Application Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Shade Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Peak Hours Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Sunglasses Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Time Spent in the Sun to get Tan Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
measure: Change in Tanning Behaviors Assessed Via Youth Risk Behavioral Surveillance System
timeFrame: Baseline Assessment (Wk 0), Post-Assessment (Wk 32-36), Follow-up #1 (Wk 36-40), Follow-up #2 (Wk 44-52), Follow-up #3 (Wk 84-88)
Secondary outcomes:
measure: Change in Sunburn Occurrence Assessed Via Sun Habits Survey
timeFrame: Baseline (Wk 0), Post-Intervention (32-36 Wks), Follow-Up 1 (36-40 Wks), Follow-Up 2 (44-52 Wks), Follow-Up 3 (84-88 Wks)
measure: Change in Ultraviolet Radiation (UVR) Exposure Assessed Via UVR Monitor
timeFrame: Baseline (Wk 0), Post-Intervention (32-36 Wks), Follow-Up 1 (36-40 Wks), Follow-Up 2 (44-52 Wks), Follow-Up 3 (84-88 Wks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Yelena Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: