Sun-safe Habits Intervention and Education

NCT04341064 | Completed Phase 3

• 2 other identifiers: IRB_001186201R01CA244674-01
• Study Type: interventional
• Target: 2,223
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer; Adolescents

Keywords

Education; Prevention and Control; Behavioral Research

Outcome Measures

Primary Outcomes (9)

• Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in sunscreen application occurrence between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you wear sunscreen?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Sunscreen Re-Application Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in sunscreen re-application occurrence between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in long sleeved shirt occurrence between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you wear a shirt with sleeves that covered your shoulders?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in long pants/skirt occurrence between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Shade Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in shade occurrence between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Peak Hours Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in avoidance of peak hours between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Sunglasses Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in wearing sunglasses between timepoints. "These next questions ask about what you have typically done in the past month when you were outdoors in the sun for 1 hour or more. How often did you wear sunglasses?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Time Spent in the Sun to get Tan Behavior Changes Assessed Via Sun Habits Survey

  Mean/standard deviation of the difference in time spent in the sun to get tan between timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you spend time in the sun in order to get a tan?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  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)

• Change in Tanning Behaviors Assessed Via Youth Risk Behavioral Surveillance System

  Mean/standard deviation of the difference in student's indoor and outdoor tanning behaviors within the last month will be assessed using items from the Youth Risk Behavioral Surveillance System. Unintentional outdoor tanning will also be assessed. "In the past (time frame), how many times did you use an indoor tanning device such as a sunlamp, sunbed or tanning booth? (Do not count getting a spray-on tan)." Minimum value = 0; Maximum value = 5; Higher scores indicate a worse outcome "In the past (time frame), how many times did you sunbathe or tan outdoors?" Minimum value = 0; Maximum value = 5; Higher scores indicate a worse outcome "In the past (time frame), how many times did you end up with a tan, even if you didn't try to get one?" Minimum value = 0; Maximum value = 5; Higher scores indicate a worse outcome

  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 (2)

• Change in Sunburn Occurrence Assessed Via Sun Habits Survey

  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)

• Change in Ultraviolet Radiation (UVR) Exposure Assessed Via UVR Monitor

  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)

Study Arms (2)

SHINE

EXPERIMENTAL

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.

Behavioral: SHINE Intervention

Standard Education

NO INTERVENTION

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

Interventions

SHINE Intervention BEHAVIORAL

\[see arm/group descriptions\]

SHINE

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Students will be excluded from participation if they:
• Do not speak English.
• Are unable to participant due to a developmental delay.

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yelena Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: September 14, 2020
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)