Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Skin Cancer

Treatments: Behavioral: Precision Prevention Booklet; Behavioral: Standard Prevention Booklet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07222995

MCC-23436

Details and patient eligibility

About

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.

Enrollment: 2,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,900 participants in 3 patient groups

Precision Prevention Intervention

Active Comparator group

Description:

Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.

Treatment:

Behavioral: Precision Prevention Booklet

Standard Prevention

Active Comparator group

Description:

Participants receive standard skin cancer prevention materials.

Treatment:

Behavioral: Standard Prevention Booklet

Non-Intervention

No Intervention group

Description:

Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.