Trial Information

A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services 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.