- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06694571
Sun Protection and Tanning Awareness in Rural Schools (STARS)
STARS (Sun Protection and Tanning Awareness in Rural Schools)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The STARS study pilot tests a skin cancer prevention intervention adapted for use in rural schools. Participants will be recruited from approximately 14 districts in Utah. We have established collaborations with schools, districts, and the Utah State Board of Education (USBE) and they are committed to partnering with us on this project.
The research coordinator will contact district-level officials who will be asked to express their support of the study when facilitating the coordinator's contact with school principals and teachers (e.g., health teachers, science teachers). The research coordinator will also directly contact school principals and teachers to discuss participation in the study.
An intervention visit, lasting up to 90 minutes, will take place immediately following completion of a baseline survey. This intervention visit may be divided into 2 days, depending on the length of the class periods at the participating schools. During the intervention visit, students will receive general education on skin cancer and skin cancer prevention, complete a skin cancer risk self-assessment tool, and create a sun protection action plan for an outdoor activity.
One month later, participants will receive a brief (15-minute) post-intervention survey via email and/or text.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84109
- Huntsman Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students are eligible if they are enrolled in a Utah high school (e.g. grades 9-12).
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Skin cancer prevention education
Program components of a rural-adapted skin cancer prevention intervention (i.e., education, action planning exercise, risk assessment activity) will be co-implemented by the research team and participating school staff during a single- or double-session, in-class visit lasting up to 90 minutes.
Students will be asked to complete surveys at baseline and one month post-intervention.
|
An intervention visit, lasting up to 90 minutes, will take place during fall, immediately following completion of a baseline survey. This intervention visit may be divided into 2 days, depending on the length of the class periods at the participating schools. During the intervention visit, participants will receive general education on skin cancer and skin cancer prevention, complete a skin cancer risk self-assessment tool, and create a sun protection action plan for an outdoor activity. One month later, participants will receive a brief (15-minute) post-intervention survey via email and/or text. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sun Protection Index Scores - Weekday
Time Frame: Baseline and One-month time points, up to one month
|
Surveys (a baseline and a 1 month follow-up) will assess changes in sun protection, measured as an average of the frequency of sun protection items (on a 1-5 scale).
Lower scores indicate less sun protection, and higher scores indicate more sun protection.
The outcome variable is value at one month minus value at baseline.
|
Baseline and One-month time points, up to one month
|
|
Sun Protection Index Scores - Weekend Day
Time Frame: Baseline and One-month time points, up to one month
|
Surveys (a baseline and a 1 month follow-up) will assess changes in sun protection, measured as an average of the frequency of sun protection items (on a 1-5 scale).
Lower scores indicate less sun protection, and higher scores indicate more sun protection.
The outcome variable is value at one month minus value at baseline.
|
Baseline and One-month time points, up to one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tammy K Stump, PhD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Skin Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin and Connective Tissue Diseases
- Melanoma
- Skin Neoplasms
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 174239
- UM1TR004409 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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