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

Completed

• Conditions: Hereditary Breast and Ovarian Cancer
• Interventions: Other: Breast Cancer Genetics Referral Screening Tool 3.0; Other: Standard Handout; Other: Physician Notification; Other: Automatic Follow-Up by Genetic Counseling Staff

• Registration Number: NCT02786147
• Lead Sponsor: Emory University

Brief 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).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-05-30
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 665

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physician Notification	Breast Cancer Genetics Referral Screening Tool 3.0	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.
Physician Notification	Physician Notification	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.
Patient Initiated	Standard Handout	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.
Patient Initiated	Breast Cancer Genetics Referral Screening Tool 3.0	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.
Physician Notification	Standard Handout	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.
Automatic Follow-Up By Genetic Counseling Staff	Automatic Follow-Up by Genetic Counseling Staff	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.
Automatic Follow-Up By Genetic Counseling Staff	Breast Cancer Genetics Referral Screening Tool 3.0	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.
Automatic Follow-Up By Genetic Counseling Staff	Standard Handout	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.

Primary Outcome Measures

Name	Time	Method
Number of B-RST screen positive participants who are referred to cancer genetic counseling via Self-Referral, Physician Notification by EeMR, Direct Contact by Cancer Genetics Program	18 Months from Baseline
Number of participants who complete cancer genetic counseling after Self-Referral, Physician Notification by EeMR, Direct Contact by Cancer Genetics Program	18 Months from Baseline

Secondary Outcome Measures

Name	Time	Method
Number of participants who underwent genetic testing after genetic counseling	18 Months from Baseline
Number of participants who were identified with a BRCA1/2 mutation	18 Months from Baseline
Number of participants who were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services	18 Months from Baseline
Number of participants who were identified with a mutation in a different hereditary cancer gene	18 Months from Baseline

Trial Locations

Locations (2)

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States