4R for Guideline Indicated BRCA Testing of Breast Center Patients (4R)
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|ClinicalTrials.gov Identifier: NCT01320540|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : August 3, 2016
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast 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 patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time 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 breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, 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 during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, 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 breast imaging. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.
|Condition or disease|
|Newly Diagnosed Carcinoma of Breast Genetic Predisposition to Disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||75 participants|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Breast Center 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).
- The timing of genetic testing in regards to what kind of surgery was performed [ Time Frame: 36 months ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320540
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Melissa Simon, MD||Northwestern University|