Abstract LB232: Implementation of population-based risk assessment for hereditary cancer in primary care: Results from the Early Detection of Genetic Risk (EDGE) Trial
Authors: Swisher Elizabeth M. , Harris Heather M. , Norquist Barbara M. , Brant Jeannine , Shirts Brian , Knerr Sarah , Dusic Emerson J. , Beers Faith , Theoryn Tesla N. , Cameron DaLaina , Cabral Howard , Riemann Laurie A. , Raff Michael , Devine Beth , Bowen Deborah J. , Wang Catharine 
Published: April 2024

The EDGE (Early Detection of GEnetic risk) trial compared two population-based engagement strategies for identifying primary care patients with a family or personal history of cancer and offered eligible individuals genetic testing for cancer susceptibility (GT). A total of twelve clinics from two healthcare systems (6 clinics each) participated in Montana, Wyoming and Washington State. Clinics were cluster-randomized to one of two engagement approaches: 1) point of care screening (POC), conducted by clinic staff when a patient came in for their appointment and 2) direct patient engagement (DPE), where letter and email outreach facilitated online home screening. Patients who completed screening and met pre-specified personal and family history criteria were offered GT via a home-delivered saliva kit at no cost. The two primary outcomes of the trial were the fraction of active clinic patients who 1) completed the risk assessment tool and 2) completed GT. Logistic regression models were used to compare POC and DPE, allowing for overdispersion and including clinic as a design factor. Analyses in the screened population were adjusted for age, sex, personal and/or family history of cancer, and healthcare system. Over a 12-month engagement window, 95,623 patients were seen in the 12 clinics (Table 1). The POC approach resulted in a higher proportion screened for hereditary risk (19.1% vs. 8.7%), but a similar proportion completed testing (1.5% vs. 1.6%). Notably, the rate of testing among eligible patients approached via POC was approximately half the rate observed with DPE (24.7% vs. 44.7%). POC screen completers were less likely to have a personal history of cancer (9.1% vs. 10.7%), a significant family history of cancer (9.5% vs. 12.8%), and, if eligible, order a test kit (33.8% vs. 58.1%). Overall, a POC approach resulted in higher screening rates for familial cancer risk but a similar fraction completing GT, with DPE screeners self-selecting due to greater personal and/or family history of cancer. Analyses are ongoing to examine patient, clinic and system-level factors predicting screening and testing uptake, which can inform best practices for population-based hereditary cancer screening efforts.

POC % (N) DPE % (N) Unadjusted OR (POC vs DPE) Adjusted OR * (POC vs DPE) p-value Patient Denominator 51,693 43,930 Completed Screening 19.1% (9892) 8.7% (3813) 2.49 - 0.0074 Completed GT 1.5% (757) 1.6% (717) 0.89 - 0.75 Screened Participants 9892 3813 % screened with any personal cancer history 9.1% (902) 10.7% (406) 0.77 &lt;0.0001 % of screened with significant** family history of cancer 9.5% (935) 12.8% (487) - 0.69 &lt;0.0001 % of screened found eligible for GT 31.0% (3070) 42.0% (1603) - 0.65 &lt;0.0001 Participants eligible for GT 3070 1603 % of eligible who ordered test kit 33.8% (1039) 58.1% (932) - 0.43 &lt;0.0001 % of eligible who completed GT 24.7% (757) 44.7% (717) - 0.49 &lt;0.0001 *Adjusted ORs - Adjusted for age, sex, personal cancer history, family cancer history, healthcare system.**Significant family history: 2 or more first degree relatives with a high-risk cancer

Citation Format: Elizabeth M. Swisher, Heather M. Harris, Barbara M. Norquist, Jeannine Brant, Brian Shirts, Sarah Knerr, Emerson J. Dusic, Faith Beers, Tesla N. Theoryn, DaLaina Cameron, Howard Cabral, Laurie A. Riemann, Michael Raff, Beth Devine, Deborah J. Bowen, Catharine Wang. Implementation of population-based risk assessment for hereditary cancer in primary care: Results from the Early Detection of Genetic Risk (EDGE) Trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB232.