Recruiting NCT07222995
Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Precision Prevention Booklet, Standard Prevention Booklet.
- Who it may be relevant to
- Registry conditions: Skin Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers
Overview
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
- 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. - Behavioral Standard Prevention Booklet
Standard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk.
Primary outcome measures
- Change in Tanning Score [Time frame: Baseline, 6 months, 12 months]
- Number of Sunburns [Time frame: Baseline, 6 months, 12 months]
- Skin self-examination (SSE) [Time frame: Baseline, 6 months, 12 months]
- Physician-patient communication about skin cancer prevention. [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (3)
- Change in Hours Spent Outside in the Sun [Time frame: Baseline, 6 months, 12 months]
- Change in Sun Protection Behaviors [Time frame: Baseline, 6 months, 12 months]
- Receipt of Total Body Skin Examination (TBSE) [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Moffitt Cancer Center — Tampa
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT07222995 · MCC-23436