A hybrid effectiveness-implementation trial to integrate precision skin cancer risk feedback in federally qualified health centers - 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.
