4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients
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
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
of the intervention, 03/01/2011 and 05/31/2012. The EDW and NMFF and NMH medical record
systems will be used to collect this information.
Because the intervention and retrospective and prospective chart reviews pose minimal risk
to the subjects and locating the patients or having access to the patients would be time and
cost prohibitive, a waiver of consent and HIPAA is requested.
ASSESS IMPACT OF THE INTERVENTION
Study investigators will conduct interviews with a total of 6 breast cancer patients and 12
Northwestern staff to determine if the intervention improved the care process. Written
consent will be obtained from all interview participants. Participants will have the option
of being audiotaped. Audiotaping is not required.
- Prior to the intervention, investigators will interview 6 breast cancer patients and 12
Northwestern staff to find out about the current care process and opinions/feedback on
- Following the intervention, 6 patients and 12 staff will be interviewed using the same
questions and format. It is acceptable that the individuals participating in the
post-intervention interview are not the same as those participating in the
INTERVENTION TEST/INTERVENTION IMPLEMENTATION
The intervention will be tested with women age 18 and older who have a history of
genetic/familial risk and patients at the Lynn Sage Comprehensive Breast Center between
March 1, 2013 and February 28, 2014. There will be no follow up on these patients after
March 31, 2014..
1. Select breast center patients who consent to participate in this study will take a
basic familial/genetic risk survey that follows NCCN guidelines (up to 2,000 patients
will be consented into this study, with a sub-cohort of up to 300 who are identified to
have a familial / genetic risk for breast cancer. If no risk is identified, the
patient is not specifically informed of genetic counseling.
2. For study consented breast center patients with familial / genetic risk, the cancer
genetics program will provide information about genetic counseling. The research staff
will track those patients who receive information about genetic counseling.
Observational Model: Cohort, Time Perspective: Prospective
The timing of genetic testing in regards to what kind of surgery was performed
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).
Julian Schink, MD
United States: Institutional Review Board
|Northwestern Memorial Hospital||Chicago, Illinois 60611|