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NCT Number: NCT07222995

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

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.

Recruiting

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precision Prevention Booklet

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 Booklet

Behavioral

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

Primary outcomes

  1. Change in Tanning Score

    Time frame: Baseline, 6 months, 12 months

    Change in self-reported tanning behavior score from baseline to 6 and 12 months.

  2. Number of Sunburns

    Time frame: Baseline, 6 months, 12 months

    Change in self-reported number of sunburns experienced over the past 6 and 12 months.

  3. Skin self-examination (SSE)

    Time frame: Baseline, 6 months, 12 months

    Change in self-reported SSE from baseline to 6 and 12 months.

  4. Physician-patient communication about skin cancer prevention.

    Time frame: Baseline, 6 months, 12 months

    Change in self-reported physician-patient communication from baseline to 6 and 12 months.

Secondary outcomes

  1. Change in Hours Spent Outside in the Sun

    Time frame: Baseline, 6 months, 12 months

    Change in self-reported average weekly hours spent outdoors in direct sunlight, assessed via questionnaire.

  2. Change in Sun Protection Behaviors

    Time frame: Baseline, 6 months, 12 months

    Change in frequency of sun protection behaviors, including use of sunscreen, wearing protective clothing, and seeking shade, assessed via a composite behavior scale.

  3. Receipt of Total Body Skin Examination (TBSE)

    Time frame: 12 months

    Proportion of participants who report referral for and receiving a total body skin examination by a healthcare professional during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Rania Abdulla

CONTACT

[email protected]

813-745-6813

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 31, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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