Integrating personalized skin cancer risk feedback into community health centers

A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers

This project tests whether giving adult patients personalized skin cancer risk information based on genetics and recent sun behaviors increases use of sun-protection and prevention activities at Tampa Family Health Centers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (other)
• Locations: 2 sites (Tampa, Florida and 1 other locations)
• Trial ID: NCT07222995 on ClinicalTrials.gov

What this trial studies

This hybrid effectiveness-implementation project compares a precision prevention booklet that incorporates MC1R genetic risk information to a standard prevention booklet among adult patients at six Tampa Family Health Centers. Participants complete a baseline questionnaire, provide a saliva sample for MC1R genotyping, and receive one of the two prevention booklets tailored by language (English or Spanish). The study measures uptake of skin cancer prevention behaviors and examines how different messages about risk affect those behaviors and the feasibility of delivering genetic risk feedback in a safety-net setting. Outcomes will inform whether integrating personalized genetic and behavioral risk information is acceptable and effective in federally qualified health centers.

Who should consider this trial

Good fit: Adults (18+) who are patients at one of the six Tampa Family Health Centers, report recent sunburn or intentional/unintentional tanning in the past year, can provide informed consent, and are willing to complete questionnaires and provide a saliva sample are ideal candidates.

Not a fit: People under 18, those who report no tanning or sunburn in the past 12 months, or those unwilling/unable to complete the baseline assessment or provide a saliva sample are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, personalized MC1R risk feedback could encourage patients to adopt stronger sun-protection habits, potentially lowering future skin cancer risk.

How similar studies have performed: Previous work using personalized genetic risk messages, including MC1R-related melanoma risk, has produced modest behavior change in some studies but results are mixed and implementing this approach in federally qualified health centers is relatively novel.

Eligibility criteria

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.

Where this trial is running

Tampa, Florida and 1 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Peter Kanetsky, PhD, MPH — Moffitt Cancer Center
• Study coordinator: Rania Abdulla

Conditions: Skin Cancer