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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
2R01CA074861-06A2
Application #
6870872
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Mc Donald, Paige A
Project Start
1997-08-01
Project End
2009-08-31
Budget Start
2004-09-30
Budget End
2005-08-31
Support Year
6
Fiscal Year
2004
Total Cost
$488,598
Indirect Cost
Name
Georgetown University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
049515844
City
Washington
State
DC
Country
United States
Zip Code
20057
Schwartz, Marc D; Peshkin, Beth N; Isaacs, Claudine et al. (2018) Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients. Breast Cancer Res Treat 170:517-524
King, Lesley; O'Neill, Suzanne C; Spellman, Elizabeth et al. (2013) Intentions for bilateral mastectomy among newly diagnosed breast cancer patients. J Surg Oncol 107:772-6
Graves, Kristi D; Peshkin, Beth N; Halbert, Chanita H et al. (2007) Predictors and outcomes of contralateral prophylactic mastectomy among breast cancer survivors. Breast Cancer Res Treat 104:321-9
Tercyak, Kenneth P; Peshkin, Beth N; Brogan, Barbara M et al. (2007) Quality of life after contralateral prophylactic mastectomy in newly diagnosed high-risk breast cancer patients who underwent BRCA1/2 gene testing. J Clin Oncol 25:285-91
Schwartz, Marc D; Lerman, Caryn; Brogan, Barbara et al. (2005) Utilization of BRCA1/BRCA2 mutation testing in newly diagnosed breast cancer patients. Cancer Epidemiol Biomarkers Prev 14:1003-7
Schwartz, Marc D; Lerman, Caryn; Brogan, Barbara et al. (2004) Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients. J Clin Oncol 22:1823-9
Cullen, Jennifer; Schwartz, Marc D; Lawrence, William F et al. (2004) Short-term impact of cancer prevention and screening activities on quality of life. J Clin Oncol 22:943-52
Lerman, Caryn; Croyle, Robert T; Tercyak, Kenneth P et al. (2002) Genetic testing: psychological aspects and implications. J Consult Clin Psychol 70:784-97
Schwartz, Marc D; Peshkin, Beth N; Hughes, Chanita et al. (2002) Impact of BRCA1/BRCA2 mutation testing on psychologic distress in a clinic-based sample. J Clin Oncol 20:514-20
Hughes, Chanita; Lerman, Caryn; Schwartz, Marc et al. (2002) All in the family: evaluation of the process and content of sisters' communication about BRCA1 and BRCA2 genetic test results. Am J Med Genet 107:143-50

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