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1 This is great information, but how do I use it?: Information needs of genetic counselors related to reclassification of Variants of Uncertain Significance Courtney Scherr, PhD Moffitt Cancer Center Teri Malo, PhD Moffitt Cancer Center Noralane Lindor, MD Mayo Clinic, Scottsdale Fergus Couch, PhD Mayo Clinic, Rochester Susan Vadaparampil PhD Moffitt Cancer Center Conflicts of Interest I, or an immediate family member, including my spouse or partner, have NO financial i relationship(s) relevant to the content of this educational activity. 1
2 Learning Objectives Identify challenges in communicating uncertain ti complex scientific information from the bench to the bedside. Describe a method for creating effective communication between scientists and providers. Lifetime risk of can ncer 60% 50% 40% 30% 20% 10% 13% 55% 60% 17% 59% BRCA 1 Mutation BRCA 2 Mutation 0% 1% General Population Breast Cancer Ovarian Cancer Mavaddat, N. et al. (2013) Journal of the National Cancer Institute 2
3 Genetic Counseling and Testing Makes an appointment and attends pre test genetic counseling The patient decides to have genetic testing The genetic counselor receives the results The genetic counselor discloses the result to the patient in a post test genetic counseling session Genetic Test Results 3
4 Variant Of Uncertain Significance Overestimation of risk Additional worry or anxiety Miscommunication with family members Had surgeries not clinically recommended or advised based on VUS result We knew patients struggled with VUS results, but we didn t know how Genetic Counselor s dealt with them IARC Classification 5 Definition Definitely Pathogenic (Harmful) Posterior Probability Score > Likely Pathogenic Uncertain Likely Not Pathogenic Not Pathogenic (Not Harmful) <
5 REVIEW ARTICLE OFFICIAL JOURNAL A Review of a Multifactorial Probability-Based Model for Classification of BRCA1 and BRCA2 Variants of Uncertain Significance (VUS) Human Mutation paper academic paper not highly accessible Noralane M. Lindor, 1 Lucia Guidugli, 2 Xianshu Wang, 2 Maxime P. Vallé e, 3 Alvaro N. A. Monteiro, 4 Sean Tavtigian, 5 David E. Goldgar, 6 and Fergus J. Couch 2,7 1 Departments of Medical Genetics; 2 Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota; 3 International Agency for Research on Cancer, Lyon, France; 4 Cancer Epidemiology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; 5 Department of Oncological Sciences, Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah; 6 Department of Dermatology, University of Utah School of Medicine, Salt Lake City, Utah; 7 Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota Communicated by Dominique Stoppa-Lyonnet Received 16 May 2011; accepted revised manuscript 26 September Published online 11 October 2011 in Wiley Online Library ( /humu Specific Aims Specific Aim 1: To classify BRCA1 and BRCA2 VUS using a multifactorial t i l likelihood lih model. Specific Aim Aim 2: To 3: establish Translation the utility of VUS functional analysis for classifying BRCA2 VUS reclassification to clinical practice as deleterious or neutral. 5
6 Translation of VUS Reclassification to Clinical Practice YEARS 1/2 Baseline survey mailing includes Human Mutation paper. Analyze data YEARS 2/3 Develop and refine VUS Genetic counseling aid Conduct Interviews with Genetic Counselors YEARS 3/4 Second Survey Mailing Analyze data and compare results to baseline survey YEAR 5 Refine e VUSgenetic etc counseling Aid Disseminate final VUS aid to ALL GC s Disseminate to GC s in study sample Patient Template Letter Patient letter directed to the patient Encouraged to share with family and other healthcare providers Consideration given to the reading level 6
7 Provider Focused Factsheet Sections included: What is the purpose of this guide? What information is contained in this guide? What is the best way to use this guide in my clinical practice? A word of caution. Genetic counselors identified through personal channels Pilot Interviews Geographically diverse sample 10 phone interviews Semi structured interview guide 30 minutes Informal feedback mechanism 7
8 Patient Template Letter Liked Appropriate p for their patients Would use at least part of it in their practice Constructive Feedback Could it be adapted? Emphasis on testing family members for research only. Clarification about maintaining i i contact t patient t or provider? Letter condensed to a single page. Reduce reading level. Grammatical edits. Revised layout to be reduced to a single page. Used red font to indicate modifiable aspects of the letter Modified the text to says Family members should not be tested for VUS to find out their cancer risk Revised wording to include bi directional communication. 8
9 Fact Sheet Liked Appreciated direct information sharing Liked the table format Liked word of caution section Constructive Feedback Who conducted the reclassification? How was reclassifcationconducted? What is the purpose/clinical utility of this information? How is this different from laboratory reports? How can the tables be used? What is the technical note? In addition, the following sections were added for additional clarification: Changed to: How were BRCA VUS classified? How is a VUS classified using the IARC multifactorial likelihood model? This section was retained, genetic counselors liked this This section was modified for clarity Changed to: Who developed this guide? Can functional studies be used to reclassify VUS? Some liked this section, others found it confusing, it was revised and included as a footnote on the actual reclassification tables. This section moved, and is now: What information is contained in this guide? What is the best way to use this guide in clinical practice? 9
10 Take Home Messages Communicating scientific information is challenging even to healthcare professionals It is important to consider the channel, message, tone, etc. Surveys can be useful but l l h h Piloting intervention materials with the target population is invaluable Iterative & longitudinal process Should be considered when writing grants 10
11 Acknowledgements This work was supported by the Breast Cancer Spore CA Dr. Courtney L. Scherr is supported by the R25 CA Behavioral Oncology Education and Career Development grant. This work was supported in part by the Survey Methods Core Facility at the H. Lee Moffitt Cancer Center & Research Institute; an NCI designated Comprehensive Cancer Center (P30 CA76292). Additional References Domchek SM, Bradbury A, Garber JE, Offit K, Robson ME. Multiplex genetic testing for cancer susceptibility: Out on the high wire without a net? Journal of Clinical Oncology. 2013; 31(10): Katsanis SH, Katsanis N. Molecular genetic testing and the future of clinical genomics. Nature Reviews Genetics Lindor NM, Goldgar DE, Tavtigian SV, Plon SE, Couch FJ. BRCA1/2 sequence variants of uncertain significance: a primer for providers to assist in discussions and in medical management. Oncologist. 2013;18(5): Miller Samuel S, MacDonald DJ, Weitzel JN, et al. Variants of Uncertain Significance in Breast Cancer Related Genes: Real World Implications for a Clinical Conundrum. Part One: Clinical Genetics Recommendations. Seminars in Oncology. 2011;38(4): Robson M. Multigene Panel Testing: Planning the Next Generation of Research Studies in Clinical Cancer Genetics. Journal of Clinical Oncology Domchek SM, Bradbury A, Garber JE, Offit K, Robson ME. Multiplex genetic testing for cancer susceptibility: Out on the high wire without a net? Journal of Clinical Oncology. 2013; 31(10): Vos J, Gómez García E, Oosterwijk JC, et al. Opening the psychological black box in genetic counseling. The psychological impact of DNA testing is predicted by the counselees' perception, the medical impact by the pathogenic or uninformative BRCA1/2 result. Psycho Oncology. 2012;21(1):
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