Clinical Trial 23436

• Overview

  Study Title:

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

  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.

  Objective:

  Aim 1: Determine the effectiveness of a precision intervention to improve skin cancer prevention activities. Among participants at MC1R higher risk, we hypothesize a (1a) decrease in tanning and sunburning and (1b) increase in self/partner skin examination (SSE) and physician-patient communication about skin cancer prevention and early detection in those receiving precision information compared to those receiving standard information. Among those at MC1R average risk, we hypothesize comparable improvements regardless of type of prevention information received. Secondary outcomes include frequency of protective activities (e.g., use of sunscreen), hours of sun exposure, and referral for and completion of a total body skin examination by a health professional. We will explore demographics and social determinants of health as moderating variables to identify subgroups for which intervention adaptation can improve effectiveness. Aim 2: Assess the equity of implementation outcomes using mixed methods. Using quantitative and qualitative methods informed by the RE-AIM QuEST framework, we will evaluate reach, adoption, implementation, and maintenance of the intervention and assess implementation equity across strata of demographics (e.g., ethnicity and sex), risk factors (e.g., family history), and social determinants of health (e.g., education) to inform maximal implementation and scalability of the precision intervention. Exploratory Aim 3: Explore theoretically-informed mediators of improved prevention behaviors. We will conduct exploratory analyses of measures of perceived threat and control based in Protection Motivation Theory as mechanisms through which the intervention impacts change in skin cancer prevention activities. Exploratory Aim 4: Explore the impact of a precision intervention to improve sun protection behaviors in children of study participants.

• Inclusion 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

  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.

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