NCT07222995

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,900

participants targeted

Target at P75+ for not_applicable

Timeline
54mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Oct 2025Oct 2030

Study Start

First participant enrolled

October 10, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2030

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

October 28, 2025

Last Update Submit

February 3, 2026

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Precision Prevention Intervention

ACTIVE COMPARATOR

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

Behavioral: Precision Prevention Booklet

Standard Prevention

ACTIVE COMPARATOR

Participants receive standard skin cancer prevention materials.

Behavioral: Standard Prevention Booklet

Non-Intervention

NO INTERVENTION

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

Interventions

Precision Prevention BookletBEHAVIORAL

Precision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk representations and simple language.

Precision Prevention Intervention
Standard Prevention BookletBEHAVIORAL

Standard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk.

Standard Prevention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter Kanetsky, PhD, MPH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania Abdulla

CONTACT

813-745-6813Rania.Abdulla@moffitt.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2025

First Posted

October 31, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

October 10, 2030

Study Completion (Estimated)

October 10, 2030

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

US(2)