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Grant Details

Grant Number: 5R01CA248739-03 Interpret this number
Primary Investigator: Sweet, Kevin
Organization: Ohio State University
Project Title: A Randomized Controlled Trial: Genetic Counseling Patient Preference Intervention Via Electronic Health Record Portal Vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
Fiscal Year: 2023


PROJECT SUMMARY Women at elevated risk for breast cancer should complete genetic counseling and may require more frequent screening or additional tests (e.g. breast magnetic resonance imaging [MRI]). Despite guidelines emphasizing the importance of genetic counseling as part of the genetic testing process, opportunities to provide genetic counseling for women at elevated breast cancer risk are often missed. Conventional genetic counseling, consisting of separate pre- and post-genetic test sessions, is not patient driven, and is labor and time intensive to meet increasing demand (workforce burden). Our overall goal is to improve the genetic counseling experience and adherence to the National Comprehensive Cancer Network (NCCN) recommendations for women at elevated breast cancer risk. The proposed randomized controlled trial (RCT) is our next step to reach our goal. A well-established interdisciplinary team will build on past work to test a novel genetic counseling patient preference (GCPP) intervention integrated within an electronic health record (EHR) portal that allows patients to indicate their preferences while directly receiving genetic test report information and post-genetic test counseling. The RCT will be conducted among 1,000 women at elevated risk for breast cancer who agree to participate in the study. Women will be randomized to: 1) GCPP via EHR patient portal; or 2) conventional genetic counseling. The efficacy of the GCPP intervention compared to conventional genetic counseling will be determined for: adherence to NCCN guidelines for having a clinical encounter every 6-12 months and an annual mammogram (and breast MRI with contrast if recommended) (Aim 1); adherence to additional NCCN recommended cancer screening (Aim 2); and accurate breast cancer genetic knowledge and perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with genetic counseling (Aim 3). An Exploratory Aim will assess patient preferences for receipt of post-genetic test counseling (e.g. in-person, phone, video-based Skype). The proposed study is innovative because it will test a novel EHR-based genetic counseling intervention in a randomized controlled trial. The study is significant because it will determine the efficacy of the GCPP intervention in a clinical care setting to address many of the limitations of conventional genetic counseling (e.g. not patient driven). The proposed research is relevant to public health by determining the degree to which a novel genetic counseling approach influences medical outcomes for women at elevated breast cancer risk. The study results may change how genetic counseling is delivered to women with elevated breast cancer risk and address the increasing burden on the genetic counseling workforce.


Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention.
Authors: Sweet K. , Reiter P.L. , Schnell P.M. , Senter L. , Shane-Carson K.P. , Aeilts A. , Cooper J. , Spears C. , Brown J. , Toland A.E. , et al. .
Source: Contemporary clinical trials, 2023 Oct; 133, p. 107323.
EPub date: 2023-09-01.
PMID: 37661005
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Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer.
Authors: Katz M.L. , Senter L. , Reiter P.L. , Emerson B. , Ennis A.C. , Shane-Carson K.P. , Aeilts A. , Cassingham H.R. , Schnell P.M. , Agnese D.M. , et al. .
Source: Patient education and counseling, 2023 Jan; 106, p. 163-169.
EPub date: 2022-10-29.
PMID: 36333195
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