4R for Guideline Indicated BRCA Testing of Breast Center Patients
Completed
Conditions studied: Newly Diagnosed Carcinoma of Breast, Genetic Predisposition to Disease
In brief
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.
Key facts
- Study ID
- NCT01320540
- Run by
- Northwestern University
- People needed
- 75
- Starts
- 2011-03-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Retrospective chart review of 83 breast cancer patients:
- Female
- Age 18 and older
- Diagnosed with invasive breast cancer at Northwestern between 07/01/2008 and 06/30/2010
- Prospective chart review of 83 patients:
- Female
- Age 18 and older
- Diagnosed with invasive breast cancer at Northwestern between 03/01/2011 and 05/31/2012
- For patient interviews:
- Female
- Age 18 and older
- Are not inpatients
- Patients seen at the Lynn Sage Comprehensive Breast Center
- For staff interviews:
- 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)
You may not qualify if…
- Under 18 years of age
- To test the intervention, patients seen at the breast center:
- Are female
- Are age 18 and older
- Are not institutionalized
- Are being seen at the Lynn Sage Comprehensive Breast Center
- Have a positive family history per NCCN guidelines on genetic/familial high risk assessment for breast and ovarian cancer
- Exclusion Criteria:
- Under 18 years of age
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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