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Grant Details

Grant Number: 5R01CA074861-10 Interpret this number
Primary Investigator: Schwartz, Marc
Organization: Georgetown University
Project Title: Decisions & Outcomes of BRCA1/2 Test for Breast Patients
Fiscal Year: 2008


Abstract

DESCRIPTION (provided by applicant): Though there has been considerable recent research on genetic testing for breast-ovarian cancer susceptibility, most of it has focused on breast cancer survivors and their unaffected relatives. However, BRCA1/2 mutation status is also relevant for treatment decision-making in newly diagnosed breast cancer patients. Breast cancer patients who carry a BRCA1/2 mutation have up to a 65% risk of developing contralateral breast cancer. As a result, bilateral mastectomy has emerged as a viable treatment option for these patients. Although guidelines suggest that breast cancer patients with a family history suggestive of hereditary breast cancer should be referred for genetic evaluation, they do not indicate when patients should be referred with respect to their definitive treatment. As a result there is disagreement regarding the optimal timing of genetic risk assessment. There are potential advantages and disadvantages to pre-surgical referral. To date, however, there have been no controlled trials to evaluate the outcomes of pre-surgical genetic counseling. In our previous study, we evaluated the feasibility and impact of pre-surgical BRCA1/2 counseling and testing in a research sample of self-selected patients. This study demonstrated an impact of genetic counseling on surgery decisions and quality of life. However, these results are limited by participant selection factors and the lack of random assignment. Thus, we propose a novel randomized trial to evaluate the impact of pre-surgical genetic counseling (versus usual care) for newly diagnosed breast cancer patients. Guided by the Ottawa Decision Support Framework, the specific aims, of the proposed trial are: 1) To evaluate the impact of Rapid Genetic Counseling (RGC) vs. Usual Care (UC) oh medical decisions', 2) To evaluate the impact of RGC vs. UC on quality of life and psychosocial well-being; 3) To identify baseline factors that predict who is most and least likely to benefit from RGC; and 4) to evaluate the cost effectiveness of the RGC intervention.



Publications

Predictors of genetic testing uptake in newly diagnosed breast cancer patients.
Authors: Ladd M.K. , Peshkin B.N. , Isaacs C. , Hooker G. , Willey S. , Valdimarsdottir H. , DeMarco T. , O'Neill S. , Binion S. , Schwartz M.D. , et al. .
Source: Journal of surgical oncology, 2020 Aug; 122(2), p. 134-143.
EPub date: 2020-04-28.
PMID: 32346886
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Predictors of contralateral prophylactic mastectomy in genetically high risk newly diagnosed breast cancer patients.
Authors: Tynan M. , Peshkin B.N. , Isaacs C. , Willey S. , Valdimarsdottir H.B. , Nusbaum R. , Hooker G. , O'Neill S.C. , Jandorf L. , Kelly S.P. , et al. .
Source: Breast cancer research and treatment, 2020 Feb; 180(1), p. 177-185.
EPub date: 2020-01-01.
PMID: 31894446
Related Citations

Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients.
Authors: Schwartz M.D. , Peshkin B.N. , Isaacs C. , Willey S. , Valdimarsdottir H.B. , Nusbaum R. , Hooker G. , O'Neill S. , Jandorf L. , Kelly S.P. , et al. .
Source: Breast cancer research and treatment, 2018 Aug; 170(3), p. 517-524.
EPub date: 2018-04-02.
PMID: 29611029
Related Citations

Intentions for bilateral mastectomy among newly diagnosed breast cancer patients.
Authors: King L. , O'Neill S.C. , Spellman E. , Peshkin B.N. , Valdimarsdottir H. , Willey S. , Leventhal K.G. , DeMarco T. , Nusbaum R. , Feldman E. , et al. .
Source: Journal of surgical oncology, 2013 Jun; 107(7), p. 772-6.
EPub date: 2012-12-27.
PMID: 23280632
Related Citations

Predictors and outcomes of contralateral prophylactic mastectomy among breast cancer survivors.
Authors: Graves K.D. , Peshkin B.N. , Halbert C.H. , DeMarco T.A. , Isaacs C. , Schwartz M.D. .
Source: Breast cancer research and treatment, 2007 Sep; 104(3), p. 321-9.
EPub date: 2006-10-26.
PMID: 17066320
Related Citations

Quality of life after contralateral prophylactic mastectomy in newly diagnosed high-risk breast cancer patients who underwent BRCA1/2 gene testing.
Authors: Tercyak K.P. , Peshkin B.N. , Brogan B.M. , DeMarco T. , Pennanen M.F. , Willey S.C. , Magnant C.M. , Rogers S. , Isaacs C. , Schwartz M.D. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2007-01-20; 25(3), p. 285-91.
EPub date: 2006-12-11.
PMID: 17159191
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Utilization of BRCA1/BRCA2 mutation testing in newly diagnosed breast cancer patients.
Authors: Schwartz M.D. , Lerman C. , Brogan B. , Peshkin B.N. , Isaacs C. , DeMarco T. , Halbert C.H. , Pennanen M. , Finch C. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2005 Apr; 14(4), p. 1003-7.
PMID: 15824179
Related Citations

Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients.
Authors: Schwartz M.D. , Lerman C. , Brogan B. , Peshkin B.N. , Halbert C.H. , DeMarco T. , Lawrence W. , Main D. , Finch C. , Magnant C. , et al. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2004-05-15; 22(10), p. 1823-9.
EPub date: 2004-04-05.
PMID: 15067026
Related Citations

Short-term impact of cancer prevention and screening activities on quality of life.
Authors: Cullen J. , Schwartz M.D. , Lawrence W.F. , Selby J.V. , Mandelblatt J.S. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2004-03-01; 22(5), p. 943-52.
PMID: 14990651
Related Citations

Genetic testing: psychological aspects and implications.
Authors: Lerman C. , Croyle R.T. , Tercyak K.P. , Hamann H. .
Source: Journal of consulting and clinical psychology, 2002 Jun; 70(3), p. 784-97.
PMID: 12090383
Related Citations

All in the family: evaluation of the process and content of sisters' communication about BRCA1 and BRCA2 genetic test results.
Authors: Hughes C. , Lerman C. , Schwartz M. , Peshkin B.N. , Wenzel L. , Narod S. , Corio C. , Tercyak K.P. , Hanna D. , Isaacs C. , et al. .
Source: American journal of medical genetics, 2002-01-15; 107(2), p. 143-50.
PMID: 11807889
Related Citations

Impact of BRCA1/BRCA2 mutation testing on psychologic distress in a clinic-based sample.
Authors: Schwartz M.D. , Peshkin B.N. , Hughes C. , Main D. , Isaacs C. , Lerman C. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2002-01-15; 20(2), p. 514-20.
PMID: 11786581
Related Citations

BRCA1/2 testing: complex themes in result interpretation.
Authors: Peshkin B.N. , DeMarco T.A. , Brogan B.M. , Lerman C. , Isaacs C. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001-05-01; 19(9), p. 2555-65.
PMID: 11331335
Related Citations

Spiritual faith and genetic testing decisions among high-risk breast cancer probands.
Authors: Schwartz M.D. , Hughes C. , Roth J. , Main D. , Peshkin B.N. , Isaacs C. , Kavanagh C. , Lerman C. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2000 Apr; 9(4), p. 381-5.
PMID: 10794482
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