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

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

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 Overview

• Status: Recruiting
• Conditions: Skin Cancer
• Intervention / Treatment: Behavioral: Precision Prevention Booklet; Behavioral: Standard Prevention Booklet

• Study Type: Interventional
• Enrollment (Estimated): 2900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania Abdulla; Phone Number: 813-745-6813; Email: Rania.Abdulla@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Peter Kanetsky, PhD, MPH
      • Sub-Investigator: Margaret Byrne, PhD
      • Sub-Investigator: Susan Vadaparampil, PhD
  • New York
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Precision Prevention Intervention; Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.	Behavioral: Precision Prevention Booklet; Precision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk representations and simple language.
Active Comparator: Standard Prevention; Participants receive standard skin cancer prevention materials.	Behavioral: Standard Prevention Booklet; Standard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk.
No Intervention: Non-Intervention; Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tanning Score	Change in self-reported tanning behavior score from baseline to 6 and 12 months.	Baseline, 6 months, 12 months
Number of Sunburns	Change in self-reported number of sunburns experienced over the past 6 and 12 months.	Baseline, 6 months, 12 months
Skin self-examination (SSE)	Change in self-reported SSE from baseline to 6 and 12 months.	Baseline, 6 months, 12 months
Physician-patient communication about skin cancer prevention.	Change in self-reported physician-patient communication from baseline to 6 and 12 months.	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hours Spent Outside in the Sun	Change in self-reported average weekly hours spent outdoors in direct sunlight, assessed via questionnaire.	Baseline, 6 months, 12 months
Change in Sun Protection Behaviors	Change in frequency of sun protection behaviors, including use of sunscreen, wearing protective clothing, and seeking shade, assessed via a composite behavior scale.	Baseline, 6 months, 12 months
Receipt of Total Body Skin Examination (TBSE)	Proportion of participants who report referral for and receiving a total body skin examination by a healthcare professional during the study period.	12 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Peter Kanetsky, PhD, MPH, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): October 10, 2030
• Study Completion (Estimated): October 10, 2030

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Neoplasms
• Other Study ID Numbers: MCC-23436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No