A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,900
- Locations
- 3
- Primary Endpoint
- Change in Tanning Score
Study Overview
Brief Summary
The purpose of this study is to examine how different messages about risk of skin cancer can impact the uptake of skin cancer prevention activities.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be a patient of any race or ethnicity attending one of the six Tampa Family Health Centers.
- •Be 18 years of age or older.
- •Self-report skin cancer risk behaviors within the past 12 months, including: Intentional sun exposure (e.g., outdoor or indoor tanning) or unintentional sun exposure leading to sunburn.
- •Be willing to complete a baseline questionnaire and provide a saliva sample for MC1R genotyping.
- •Be able to provide informed consent (written or electronic).
- •Prefer English or Spanish for communication and study materials.
Exclusion Criteria
- •Do not report any skin cancer risk behaviors (i.e., no tanning or sunburning in the past 12 months).
- •Are unwilling or unable to complete the baseline assessment or return the saliva kit.
- •Decline to provide informed consent.
- •Are under 18 years of age.
Arms & Interventions
Standard Prevention
Participants receive standard skin cancer prevention materials.
Intervention: Standard Prevention Booklet (Behavioral)
Non-Intervention
Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.
Precision Prevention Intervention
Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.
Intervention: Precision Prevention Booklet (Behavioral)
Outcomes
Primary Outcomes
Change in Tanning Score
Time Frame: Baseline, 6 months, 12 months
Change in self-reported tanning behavior score from baseline to 6 and 12 months.
Number of Sunburns
Time Frame: Baseline, 6 months, 12 months
Change in self-reported number of sunburns experienced over the past 6 and 12 months.
Skin self-examination (SSE)
Time Frame: Baseline, 6 months, 12 months
Change in self-reported SSE from baseline to 6 and 12 months.
Physician-patient communication about skin cancer prevention.
Time Frame: Baseline, 6 months, 12 months
Change in self-reported physician-patient communication from baseline to 6 and 12 months.
Secondary Outcomes
- Change in Hours Spent Outside in the Sun(Baseline, 6 months, 12 months)
- Change in Sun Protection Behaviors(Baseline, 6 months, 12 months)
- Receipt of Total Body Skin Examination (TBSE)(12 months)