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.
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