SUPPLEMENT ABSTRACT This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA- 20-042. The application is a proposed administrative supplement to the University of Utah (Utah)/New York University (NYU) U01 entitled ?Leveraging an electronic medical record infrastructure to identify primary care patients eligible for genetic testing for hereditary cancer and evaluate novel cancer genetics service delivery models? (U01 CA232826). The parent U01 is employing a replicable electronic health record (EHR)-based clinical decision support infrastructure to: (i) identify unaffected primary care patients who qualify for cancer genetics services based on current guidelines in the Utah and NYU healthcare systems (Aim 1); and (ii) compare two models of cancer genetics services delivery for 1,920 of these unaffected primary care patients in a randomized controlled trial (Aims 2 and 3). The parent trial will examine how race and ethnicity modify the effects of the cancer genetics services delivery models. The landscape for delivering genetics services has changed substantially due to the COVID-19 pandemic, and our pilot data suggest that patients? uptake of cancer genetic testing and access to cancer screening has been adversely affected. This supplement would provide us with an unparalleled opportunity to investigate COVID-19 impacts in two study sites with very different pandemic contexts. We propose the following Supplemental Aims: (1) Characterize healthcare experiences related to COVID-19 among the cohort of 22,208 primary care patients identified as being at increased risk for hereditary cancer; and (2) Investigate how COVID-19 impacts primary care patients? decisions about and utilization of cancer genetics services. To address Supplemental Aim 1, we will abstract EHR data to investigate COVID-19 diagnosis, SARS-CoV-2 testing, and delays in cancer screening in the identified cohort. Among the subset of the cohort invited to participate in the trial, we hypothesize that having been diagnosed with or hospitalized for COVID-19 or having had a cancelled cancer screening will negatively affect trial participation. We will also investigate differences in these COVID-19 experiences by study site (Utah vs. NYU) and race/ethnicity. To address Supplemental Aim 2, among participants in the parent trial, we will examine how the health, psychological, and financial impacts of COVID-19 affect decisions about and utilization of cancer genetic counseling and genetic testing using a combination of clinic records and questionnaire data. Based on pilot data, we hypothesize that those having higher self-reported health, psychological, and financial impacts of COVID-19 will be less likely to complete cancer genetic testing. We will examine how the effects of COVID-19 are modified by study site (Utah vs. NYU) and race/ethnicity. Together, the supplemental aims will allow us to build a comprehensive picture of how COVID-19 has affected participation in and outcomes of the parent trial. The proposed supplement would also allow us to examine whether COVID-19 is widening disparities in use of cancer genetics services by race and ethnicity.
Identifying individuals with inherited cancer susceptibility is critical for targeted cancer prevention, screening, and treatment, and strategies to assess the genetic risk of unaffected individuals before cancer occurs are needed. This study will employ an implementation science framework to test a replicable electronic health record-based clinical decision support infrastructure to automatically identify unaffected patients from 48 primary care clinics in two healthcare systems, University of Utah and New York University, who qualify for cancer genetic services (Aim 1); and, using a randomized trial design with clinic-level randomization, compare the effects of two models of cancer genetic services delivery on uptake of genetic testing (Aim 2) and adherence to management recommendations after 12 months (Aim 3) among 1,920 primary care patients.
