A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,900
- 试验地点
- 3
- 主要终点
- Change in Tanning Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Prevention
Participants receive standard skin cancer prevention materials.
干预措施: Standard Prevention Booklet (Behavioral)
Non-Intervention
Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.
Precision Prevention Intervention
Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.
干预措施: Precision Prevention Booklet (Behavioral)
结局指标
主要结局
Change in Tanning Score
时间窗: Baseline, 6 months, 12 months
Change in self-reported tanning behavior score from baseline to 6 and 12 months.
Number of Sunburns
时间窗: Baseline, 6 months, 12 months
Change in self-reported number of sunburns experienced over the past 6 and 12 months.
Skin self-examination (SSE)
时间窗: Baseline, 6 months, 12 months
Change in self-reported SSE from baseline to 6 and 12 months.
Physician-patient communication about skin cancer prevention.
时间窗: Baseline, 6 months, 12 months
Change in self-reported physician-patient communication from baseline to 6 and 12 months.
次要结局
- 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)