ABSTRACT
The incidence of skin cancer has increased over the past several decades. Limiting exposure to ultraviolet
radiation and engaging in early detection can reduce skin cancer rates and burden. However, fewer than 50%
of US adults engage in prevention strategies to reduce tanning and sunburning, and even fewer examine their
skin or receive a clinical skin examination. Providing information to diverse populations of adults about their
genetic risk for skin cancer – precision prevention – has demonstrated efficacy for improving skin cancer
prevention behaviors. Our prior precision prevention intervention trials incorporating feedback of information on
inherited variation at the melanocortin-1 receptor (MC1R) gene showed (i) significant interest, reach, and test
follow-through, (ii) intervention efficacy among participants at MC1R higher risk, and (iii) comprehensible and
acceptable materials offered in both English and Spanish. Still, our secondary analyses indicated targeted
areas for refinement of intervention materials that have potential to further enhance efficacy. Building from our
encouraging findings, we propose a multisite, hybrid type 1 effectiveness-implementation study to evaluate the
impact of a precision prevention intervention to improve skin cancer prevention in diverse patients in low
resourced, community primary care settings, and to identify barriers and facilitators of implementation to
facilitate future scale-up. We will recruit 1430 participants of any race and ethnicity from federally qualified
health centers in Tampa, Florida who report skin cancer risk activities (tanning, sunburning); 1144 will be
randomized within MC1R risk (average, higher) category to receive refined precision prevention intervention
materials anchored in MC1R results or standard (non-genetic) prevention intervention materials, and 238 will
not receive any intervention materials. Primary outcomes of tanning, sunburning, physician-patient
communication about skin cancer prevention, and skin self-examination, and secondary outcomes (hours in
the sun, self-reported sun protection behaviors, referral for and receipt of a professional skin examination) will
be assessed at baseline, 6, and 12 months. In Aim 1, we will evaluate the effectiveness of receipt of the
precision prevention intervention to improve skin cancer prevention activities over 6 and 12 months.
Effectiveness will be examined separately among participants at MC1R average and higher risk. In Aim 2, we
will theoretically-informed mediators of improvements in primary and secondary outcomes. In Aim 3, we will
assess implementation outcomes, including reach, adoption, implementation, and maintenance, and we will
assess implementation equity. We will conduct exit interviews with 30 patients and 20 healthcare workers to
assess barriers and facilitators to intervention participation. If MC1R genetic information impacts prevention
activities, a theoretical 30-50% of all skin cancers could be prevented. Study findings could direct the equitable
dissemination of the intervention nationally to other low resourced, primary care settings and safety-net
organizations.