4R for Guideline Indicated BRCA Testing of Newly Diagnosed Breast Cancer Patients
Currently, many breast cancer patients with a positive family history receive information about BRCA testing after surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001).
In this study, BRCA testing information will be delivered to this patient population shortly after receiving the breast cancer diagnosis and in ample time to be able to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the initial visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population shortly after diagnosis, and coordinate scheduling with genetic counseling services to insure patients are promptly seen.
The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling prior to their surgical decision will shift BRCA testing to before definitive breast cancer surgery and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at diagnosis. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.
Newly Diagnosed Carcinoma of Breast
Genetic Predisposition to Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients|
- The timing of genetic testing in regards to what kind of surgery was performed [ Time Frame: 36 months ] [ Designated as safety issue: No ]To test an intervention for breast cancer patients with familial/genetic risk by obtaining data on 83 women with breast cancer who were tested before the intervention was implemented and comparing their outcomes to 83 women with breast cancer who were treated after the intervention was implemented. The primary endpoint is the timing of BRCA testing relative to (before or after) definitive breast cancer surgery and the surgical decision (lumpectomy, mastectomy, bi-lateral mastectomy).
- The timing of genetic testing in regards to what kind of surgery was performed [ Time Frame: 12 months ] [ Designated as safety issue: No ]To test an intervention for breast center patients with familial/genetic risk by obtaining data on 2,000 women who consented and participated in the genetics assessment screening survey, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
- Impact of the intervention [ Time Frame: 36 months ] [ Designated as safety issue: No ]To assess the care process impact of the intervention on patients and provider staff through pre and post intervention interviews. The process impact will be assessed by comparing the questionnaires from the pre and post intervention interviews in 6 patients and 12 providers.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Newly diagnosed breast cancer patients
Patients newly diagnosed with breast cancer who did or did not have genetic testing (retrospectively and prospectively).
Staff from the Lynn Sage Comprehensive Breast Cancer Center
Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors).
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|Contact: Doreine Carsonemail@example.com|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Principal Investigator: Julian Schink, MD|
|Principal Investigator:||Julian Schink, MD||Northwestern University|