Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients

Approximately 5-10% of all breast cancer patients have hereditary breast cancer, the majority
due to an inherited mutation in the BRCA1 or BRCA2 genes (BRCA mutation carriers). Breast
cancer patients who are BRCA mutation carriers have up to a 65% risk for a new primary breast
cancer in the future. Additionally, BRCA mutation carriers have a 10-45% lifetime risk for
ovarian cancer.

Effective options to decrease these high future cancer risks are available to breast cancer
patients who learn they carry a BRCA mutation - including prophylactic mastectomy and
oophorectomy. Prophylactic mastectomy and oophorectomy reduce the risks for future primary
breast cancer and ovarian cancer, respectively, by more than 90%. Because of the high risks
for future cancer and the opportunity for effective risk reduction among mutation carriers,
national guidelines consistently recommend referral of breast cancer patients at increased
risk for hereditary breast cancer and ovarian cancer (HBOC) to genetic counseling by a
qualified genetics professional. Lack of implementation of this standard of care constitutes
an error of omission and jeopardizes patient outcomes.

We propose a cluster randomized controlled trial to compare a "passive intervention" -
dissemination of professional guidelines - with an "active intervention" - a multi-faceted
provider education and decision support intervention to improve 1) appropriate referral of
breast cancer patients at risk for HBOC to genetic counseling in the community cancer center
setting and 2) pre-surgical referral among newly diagnosed patients. Ultimately, these
results will lead to decreased breast and ovarian cancer incidence and mortality among breast
cancer patients and their family members, as well as improved outcomes of and satisfaction
with surgical decision-making.

Participant Inclusion Criteria:

- Females 18 years of age or greater

- Newly diagnosed primary breast cancer prior to initial definitive surgical treatment,
including In situ and Invasive cancer, Stages 0 - III. Pathologic confirmation of
diagnosis is required.

- Able to read and write in English or Spanish

Participant Exclusion Criteria:

- Any previous diagnosis of cancer except for non-melanoma skin cancer

- Stage IV breast cancer

- Received HBOC genetic counseling or mutation testing prior to diagnosis. If the
patient was previously tested only for a variant of uncertain clinical significance
(i.e., not for known familial mutation, Jewish ethnicity panel/Multisite 3 or
comprehensive sequencing) and documentation is provided, they remain eligible.