Grant Number:	5R01CA172743-06 Interpret this number
Primary Investigator:	Sutphen, Rebecca
Organization:	University Of South Florida
Project Title:	Impact of Brca Testing on Newly Diagnosed U.S. Breast Cancer Patients
Fiscal Year:	2018

DESCRIPTION (provided by applicant): Approximately 5 - 10% of breast cancer patients have hereditary breast and ovarian cancer syndrome (HBOC) and face future risks for second primary breast cancer, as well as ovarian cancer that are multiple times those of most breast cancer patients. Effective strategies exist for prevention and/or early detection of future cancers among these high-risk patients. Despite all this potential for the application of genomic information to improve long-term health and quality of life, unfortunately, little is known regardig the real world decisions and outcomes of breast cancer patients at risk for HBOC because essentially all of the research to date has been conducted at academic medical centers where healthcare services and, quite likely, health and quality of life outcomes are very different from those in the community setting where the vast majority of high-risk patients are currently identified and receive care. We have developed and will leverage a multidisciplinary academic-industry partnership with the nation's third-largest health insurer, Aetna and extensive interconnecting research infrastructure to conduct the first national prospective study of these critical issues. We will recruit 5000 consecutive newly diagnosed breast cancer patients undergoing BRCA testing through Aetna. We will assess participants within two weeks after receiving genetic test results (baseline) and at 12 and 24 months post-notification to accomplish our specific aims to: 1. Assess the treatment and cancer risk management decisions and outcomes of BRCA testing among newly diagnosed breast cancer patients at increased risk for HBOC. 2. Compare the choice of initial surgical treatment, cancer risk management decisions and outcomes of BRCA testing of patients who receive genetic testing results prior to surgery compared with after surgery. 3. Identify demographic, medical/family history and psychosocial factors associated with the utilization of available risk management options. 4. Assess health and quality of life outcomes associated with different genetic tests results, timing of results delivery and treatment and risk management decisions. Success in this endeavor will produce the first representative national data regarding the real world decisions and outcomes of newly diagnosed breast cancer patients undergoing genetic testing due to increased risk for HBOC and can lead to improved health policies and targeted clinical strategies to improve care for breast cancer survivors at the highest levels of future cancer risk.





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