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A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

18 Years
Not Enrolling
Breast Cancer

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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.


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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters

Outcome Description:

Site providers will be randomized and receive either the active or passive genetic counseling intervention. Post intervention, site providers will maintain a database of all newly diagnosed breast cancer patients that meet the study eligibility criteria. One year post diagnosis, subjects will be mailed an informed consent form including questionnaires from their providers. Returned patient questionnaire data along with information provided directly from site providers will be utilized to determine the rate of appropriate referral for genetic counseling.

Outcome Time Frame:

1 year post diagnosis

Safety Issue:


Principal Investigator

Rebecca Sutphen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of South Florida


United States: Data and Safety Monitoring Board

Study ID:

SCUSF 1102



Start Date:

September 2013

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • cluster
  • genetic counseling
  • breast cancer
  • HBOC
  • provider intervention
  • Breast Neoplasms



University of South Florida Research BaseTampa, Florida  33612