NCT02786147

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

Strategies to Increase the Identification, Genetic Counseling Referral and Genetic Testing for Women at Risk for Hereditary Breast and/or Ovarian Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 665 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Hereditary Breast and Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2016-05-30
• Last updated: 2018-04-20

Locations

2 sites across 1 country: United States