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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07222995
Enrollment
2900
Registered
2025-10-31
Start date
2025-10-10
Completion date
2030-10-10
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

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.

Interventions

BEHAVIORALPrecision Prevention Booklet

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

BEHAVIORALStandard Prevention Booklet

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

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Tanning ScoreBaseline, 6 months, 12 monthsChange in self-reported tanning behavior score from baseline to 6 and 12 months.
Number of SunburnsBaseline, 6 months, 12 monthsChange in self-reported number of sunburns experienced over the past 6 and 12 months.
Skin self-examination (SSE)Baseline, 6 months, 12 monthsChange in self-reported SSE from baseline to 6 and 12 months.
Physician-patient communication about skin cancer prevention.Baseline, 6 months, 12 monthsChange in self-reported physician-patient communication from baseline to 6 and 12 months.

Secondary

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

Countries

United States

Contacts

CONTACTRania Abdulla
Rania.Abdulla@moffitt.org813-745-6813
PRINCIPAL_INVESTIGATORPeter Kanetsky, PhD, MPH

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026