Extending the Diversity, Reach, and Generalizability of the WISDOM Study

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PROJECT SUMMARY/ABSTRACT The WISDOM Study (Women Informed to Screen Depending on Measures of risk) is a pragmatic trial comparing a personalized approach to breast cancer screening – in which the intensity and modality of screening is dependent upon stratified personal risk -- against the gold standard of annual screening. The goal is to determine whether a personalized approach is as safe, less morbid, better accepted by women, encourages uptake of preventive interventions, and is of higher health care value (better outcomes at less cost psychologically, physically, and financially). In this proposal `Expanding the WISDOM Study's Diversity, Reach, and Generalizability', we are seeking support to expand the study to additional sites around the country to enhance recruitment, improve study power and increase both the geographic and population diversity of study participants. By doing so, our intention is to increase the generalizability of the study results. Using a unique coverage with evidence progression model, we have secured insurance coverage and outreach collaboration from multiple payers, giving us the opportunity to enroll from an additional population of ~6 million women across multiple regions and varied ethnic and socioeconomic backgrounds. The network of sites that this proposal will enable us to add will allow us to create a collaborative group to continuously improve screening and learn who is at risk for what kind of cancer. The personalized screening arm includes a risk assessment based on family history, exposures, breast density, co-morbidity and genetic predisposition (presence of mutations in the 9 genes associated with screening and the combination of the small variation in inherited genes, the single nucleotide polymorphisms, into a polygenic risk score or PRS). Importantly, the PRS score is tailored to different ethnicities based on advances in the science of risk assessment, allowing us to translate these important findings into practice. We are using an adaptive approach in which the risk model is updated over the course of the trial as new information emerges. The personalized approach yields an integrated risk score that allows us to assign an age to start, an age to stop, a frequency of screening, and a modality for screening. The R01 Specific Aims are to: 1. Open new clinical sites with experience enrolling targeted populations and use culturally targeted materials to increase the numbers in and diversity of the WISDOM study population 2. Enhance trial enrollment and retention through national partnerships, centralized campaigns across the network and embedded analytics with real time feedback