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

NCT ID: NCT07222995

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2030-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Precision Prevention Intervention

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

Group Type ACTIVE_COMPARATOR

Precision Prevention Booklet

Intervention Type BEHAVIORAL

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

Standard Prevention

Participants receive standard skin cancer prevention materials.

Group Type ACTIVE_COMPARATOR

Standard Prevention Booklet

Intervention Type BEHAVIORAL

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

Non-Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Prevention Booklet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Kanetsky, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Rania Abdulla

Role: CONTACT

813-745-6813

Other Identifiers

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MCC-23436

Identifier Type: -

Identifier Source: org_study_id

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