Identification and Referral of Women at Risk for Hereditary Breast/Ovarian Cancer
NCT02786147 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 665
Last updated 2018-04-20
Summary
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.
Conditions
- Hereditary Breast and Ovarian Cancer
Interventions
- OTHER
-
Breast Cancer Genetics Referral Screening Tool 3.0
The B-RST is a simple yet effective validated screening tool to quickly identify individuals who may be at risk for hereditary breast and ovarian cancer and should be referred for cancer genetic counseling to formally evaluate their family history and discuss the benefits and limitations of genetic testing for hereditary breast and ovarian cancer. Clinic staff will give each patient arriving for a screening mammogram appointment a packet and briefly inform them about the opportunity to participate in a research study and that these materials can help them decide whether or not to participate. Patients who indicate that they are interested in completing the B-RST screening while in the clinic will be provided with an electronic tablet that has a secure internet browser tab open to the web-based study version of the screening tool (the B-RST 3.0).
- OTHER
-
Standard Handout
A document explaining the patient's positive test result indicating that they are at increased risk for HBOC (Hereditary Breast or Ovarian Cancer) which includes information on how to obtain cancer genetics services through Winship.
- OTHER
-
Physician Notification
Primary care physician or ordering physician will be notified vie EeMR that the patient screened positive on the B-RST. The note provides specific instructions on how to refer the patient for cancer genetic counseling services.
- OTHER
-
Automatic Follow-Up by Genetic Counseling Staff
Within 1-2 weeks after the 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.
Sponsors & Collaborators
-
Emory University
lead OTHER
Principal Investigators
-
Cecelia Bellcross, PhD, MS, CGC · Emory University
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2018-02-28
- Completion
- 2018-02-28
Countries
- United States
Study Locations
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