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Skin CancerPhase 3SHINENCT04341064

Sun-safe Habits Intervention and Education

A Phase 3 study testing SHINE Intervention in people with Skin Cancer and Adolescents, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Skin Cancer, Adolescents
What is being tested?
SHINE Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,223 participants
Where
1 siteUnited States
Study dates
14 Sep 2020to 15 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SHINE Intervention
Keywords
Education, Prevention and Control, Behavioral Research
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHINE InterventionBehavioural

    [see arm/group descriptions]

Study groups in NCT04341064
Study groupRoleWhat they receive
SHINEExperimentalParticipants 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.
Receives: Behavioral: SHINE Intervention
Standard EducationNo interventionParticipants will be randomized to receive information that covers general skin cancer education for pediatric populations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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

    Measured: 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)

  6. 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

    Measured: 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)

  7. 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

    Measured: 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)

  8. 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

    Measured: 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)

  9. 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

    Measured: 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)
  1. Change in Sunburn Occurrence Assessed Via Sun Habits Survey

    The investigators will examine whether sunburn occurrence decreased over time from pre- to post-intervention, specifically whether the odds of sunburn occurrence are lower for SHINE compared to standard education. An item from the Sun Habits Survey will ask students to report the number of sunburns they experienced within a specific time period.

    "In the past (time period), how many times did you have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.

    Measured: 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)

  2. Change in Ultraviolet Radiation (UVR) Exposure Assessed Via UVR Monitor

    The investigators will examine whether UVR exposure decreased over time from pre- to post-intervention. 10% of all participants (evenly distributed across schools and conditions) will be asked to wear a UVR monitoring device immediately following each of the five assessments. The device will be used as an objective assessment of UVR exposure, and will provide information on the participant's UVR exposure over a seven day period.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2020
  2. Study start14 Sep 2020
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341064
Sponsor's protocol ID
IRB_00118620
Other IDs
1R01CA244674-01
Acronym
SHINE
Status last verified
Oct 2025
First submitted
7 Apr 2020
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHINE Intervention in people with Skin Cancer and Adolescents, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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