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Grant Details

Grant Number: 5R03CA194643-02 Interpret this number
Primary Investigator: Scherr, Courtney
Organization: Northwestern University
Project Title: Communicate and Learn About Your Variant of Uncertain Significance (Clear Vus)
Fiscal Year: 2017


 DESCRIPTION (provided by applicant): Genetic testing among women at risk for Hereditary Breast and Ovarian Cancer can help guide the prevention, diagnosis, and treatment of a woman and her family members to reduce cancer incidence and mortality. Genetic testing used to be conducted serially, or on one gene at a time, but recent technological advances and decreasing costs have led to the ability to test multiple genes at a time, called multigene panel testing. One outcome of genetic testing that has increased due to the escalating use of multigene panel testing is the variant of uncertain significance (VUS), meaning a change in a gene was found, yet it is unknown whether the change increases predisposition to cancer or not. The VUS result is challenging for providers and has led to negative outcomes for patients including increased distress and undergoing unnecessary surgical treatments to name a few. Yet, no intervention exists to help patients understand VUS results; therefore our objective is to develop an educational booklet for patients who receive VUS results from multigene testing. The Mental Models Approach (MMA) will be used to guide the identification of content for the booklet and the Extended Parallel Process Model (EPPM) will be used to guide the framing of the content. The use of the MMA and the EPPM will result in the development of a booklet that will correct inaccurate beliefs and build on existing knowledge about VUS to help patients create an accurate mental model of VUS that can be used in judgment and decision making. Guided by the MMA, three specific aims are proposed in this study including: (1) The creation of an expert influence diagram that illustrates the concepts that cause a VUS, result from a VUS, and subsequent choices a patient has; (2) the creation of a lay-influence diagram that represents the current mental model of patients who receive VUS results; (3) the creation of an educational booklet that addresses the gaps and corrects the inaccuracies of the lay-influence diagram compared to the expert influence diagram. Using an online-focus group based approach; the expert influence diagram will be constructed by a panel of genetics experts. Individual patient interviews will be conducted to identify existing mental models of VUS, and results from the interviews will inform the development of a lay-influence diagram. A comparative analysis of the expert and lay influence diagrams will inform the content of the educational booklet and the EPPM will guide the message structure and tone. The educational booklet will be reviewed for accuracy and inclusion by the expert panelists, and then will be tested among patient focus groups with VUS results. Revisions to the booklet will be made based on results of the focus groups, and the booklet will be reviewed a final time by the expert panelists to ensure the information is accurate and comprehensive. The result of this project will be the first educational booklet developed to increase patients understanding and facilitate accurate judgment and decision making about VUS resulting from multigene testing. Once developed, this educational booklet can be modified for use with patients who receive VUS results from multigene testing for other hereditary cancers.


How patients deal with an ambiguous medical test: Decision-making after genetic testing.
Authors: Scherr C.L. , Ramesh S. , Getachew-Smith H. , Kalke K. , Ramsey K. , Fischhoff B. , Vadaparampil S.T. .
Source: Patient education and counseling, 2021 May; 104(5), p. 953-959.
EPub date: 2020-10-18.
PMID: 33214013
Related Citations

A Modern Dilemma: How Experts Grapple with Ambiguous Genetic Test Results.
Authors: Scherr C.L. , Ross Arguedas A.A. , Getachew-Smith H. , Marshall-Fricker C. , Shrestha N. , Brooks K. , Fischhoff B. , Vadaparampil S.T. .
Source: Medical decision making : an international journal of the Society for Medical Decision Making, 2020 Jul; 40(5), p. 655-668.
PMID: 32734842
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