Identification and Referral of Women at Risk for Hereditary Breast/Ovarian Cancer

Emory University

Status: Completed

Conditions: Hereditary Breast and Ovarian Cancer

Treatments: Other: Standard Handout; Other: Breast Cancer Genetics Referral Screening Tool 3.0; Other: Automatic Follow-Up by Genetic Counseling Staff; Other: Physician Notification

Study type: Observational

Funder types: Other

Identifiers

NCT02786147

IRB00084985

Details and patient eligibility

About

The purpose of this study is to identify the most effective means of follow-up for women who screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the standard clinical setting of mammography, to maximize the number who are referred to and receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be evaluated by determining the number seen who are appropriate for genetic testing, undergo genetic testing and are found to carry a hereditary cancer gene mutations with medical management implications for the patient and family. The long-term goal is to reduce the morbidity and mortality associated with hereditary causes of breast and ovarian cancer among patients seen in the Emory/Winship system.

Full description

The three aims for this study are: 1. To develop an electronic version of the revised B-RST (Breast Cancer Genetics Referral Screening Tool) with a HIPAA compliant database for integration within the Winship Cancer Institute at Emory website. 2. To identify the most effective means of follow-up to maximize the number of screen positive individuals who are referred to and complete cancer genetics counseling. 3. Evaluate the clinical utility of B-RST 3.0 by analyzing the number of individuals who were referred to and received genetic counseling and were considered appropriate for genetic testing and underwent genetic testing, and were identified with a BRCA1/2 mutation, and/or were identified with a mutation in a different hereditary cancer gene, or were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services.

The B-RST is a simple yet effective screening tool to identify individuals who may be at risk for hereditary breast and ovarian cancer. This study will seek to determine the most effective method of follow-up to maximize referral to and completion of cancer genetic counseling services following a screen positive result on the B-RST tool, and to understand clinical outcomes following participation in genetic counseling (i.e., whether patients who receive counseling undergo genetic testing, genetic testing results, and recommendations for enhanced screening and preventions).

Enrollment: 665 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient at one of the participating clinics (Winship Cancer Institute and Emory University Hospital Midtown) who arrive for a screening mammogram appointment.

Exclusion criteria

• Patients receiving a diagnostic mammogram will not be invited to participate in the study.

Trial design

665 participants in 3 patient groups

Patient Initiated

Description:

Patients randomized into this group will receive a standard handout explaining their result, which includes information on how to obtain cancer genetics services through Winship. However, neither the patient nor their ordering clinician will be directly contacted regarding the B-RST result.

Treatment:

Other: Standard Handout

Other: Breast Cancer Genetics Referral Screening Tool 3.0

Physician Notification

Description:

Patients randomized into this group will also receive the standard handout explaining their result. In addition, their primary care physician or ordering physician will be notified via Emory Electronic Medical Record (EeMR) that the patient screened positive on the B-RST. The note will provide specific instructions on how to refer the patient for cancer genetic counseling services.

Treatment:

Other: Standard Handout

Other: Breast Cancer Genetics Referral Screening Tool 3.0

Other: Physician Notification

Automatic Follow-Up By Genetic Counseling Staff

Description:

Patients randomized into this group will also receive the standard handout explaining their result. Within 1-2 weeks after their mammogram appointment, patients will receive a phone call from a genetics counseling staff person to explain their screening result and to offer to set up a genetics counseling appointment. This call may take up to 10 - 15 minutes.

Treatment:

Other: Automatic Follow-Up by Genetic Counseling Staff

Other: Standard Handout

Other: Breast Cancer Genetics Referral Screening Tool 3.0