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Sun-Safe Habits Education for Skin Cancer Prevention in Adolescents (SHINE Trial)
Phase 3
Recruiting
Led By Yelena Wu, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
SHINE Trial Summary
This trial is testing whether the SHINE intervention can help high school students better protect themselves from the sun and avoid tanning.
Who is the study for?
This trial is for high school students in Utah, grades 9-12. It's designed to test if a program called SHINE can help them use sun protection and avoid intentional tanning. Students who don't speak English or have developmental delays that prevent participation are not eligible.Check my eligibility
What is being tested?
The SHINE intervention involves two in-class sessions aimed at improving sun-safe habits among adolescents. The study will compare the results of schools receiving SHINE with those getting standard education on skin cancer prevention.See study design
What are the potential side effects?
Since this trial focuses on education and behavior change rather than medication, there are no direct medical side effects expected from participating in the SHINE intervention.
SHINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Tanning Behaviors Assessed Via Youth Risk Behavioral Surveillance System
Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey
Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey
+6 moreSecondary outcome measures
Change in Sunburn Occurrence Assessed Via Sun Habits Survey
Change in Ultraviolet Radiation (UVR) Exposure Assessed Via UVR Monitor
SHINE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SHINEExperimental Treatment1 Intervention
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.
Group II: Standard EducationActive Control1 Intervention
Participants will be randomized to receive information that covers general skin cancer education for pediatric populations.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,921,500 Total Patients Enrolled
University of UtahLead Sponsor
1,103 Previous Clinical Trials
1,771,467 Total Patients Enrolled
Yelena Wu, PhDPrincipal Investigator - University of Utah
Beaver Valley Hospital
University Of Utah School Of Medicine (Medical School)
University Of Ut Medical Center (Residency)
5 Previous Clinical Trials
21,364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a developmental delay that prevents participation.I speak English.
Research Study Groups:
This trial has the following groups:- Group 1: SHINE
- Group 2: Standard Education
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would someone outside the age group of 55 still be eligible for this experiment?
"The age bracket for eligible patients in this trial are those that are over 11 but have not yet reached 21 years of age."
Answered by AI
What are some risks associated with the SHINE Intervention?
"There is some evidence to support the efficacy of SHINE Intervention, and it has received multiple rounds of safety testing, so we have given it a 3."
Answered by AI
Are people with the specific condition needed for this study currently being recruited?
"The latest information from clinicaltrials.gov shows that this study is still looking for participants. The study was originally posted on September 15th, 2020 and was updated on May 16th, 2022."
Answered by AI
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