Clinical Trial: 4R for Guideline Indicated BRCA Testing of Breast Center Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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 inte

Detailed Summary:

This study is expected to involve a total of 2,101 individuals: 89 (83 for testing the intervention and 6 who participated in interviews like Northwestern staff participants) breast cancer patients, 12 Northwestern staff,and 2,000 women who consented and participated in the genetics assessment screening survey using the tool, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.

All subjects will be assigned a unique study number to minimize the risk of a breach of confidentiality. This is the only anticipated risk to subjects participating in this study utilizing retrospective and prospective chart reviews and interviews.

TESTING THE INTERVENTION

Investigators will collect retrospective data for 83 breast cancer patients diagnosed who underwent BRCA testing and definitive breast cancer surgery at Northwestern between 07/01/2008 to 06/30/2010. This baseline information detailed on the Data Collection Form will be collected using EDW and NMFF and NMH medical record systems.

The intervention involves radiologists who convey pathology results to patients with suspected breast cancers. At the time the patient with a familial/ genetic risk is informed of a positive test result for breast cancer, the radiologist will provide information about genetic counseling and offer to send an educational handout via e-mail or regular mail. This intervention will be conducted with newly diagnosed breast cancer patients between 03/01/2011and 05/31/2012.

Investigators will prospectively collect data on these 83 breast cancer patients who are diagnosed, received BRCA testing, and had definitive surgery at Northwestern during the time
Sponsor: Northwestern University

Current Primary Outcome:

  • 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.


Original Primary Outcome: 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).


Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: March 18, 2011
Date Started: March 2011
Date Completion:
Last Updated: August 2, 2016
Last Verified: August 2016