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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

665 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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

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Hereditary Breast and Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Initiated

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.

Breast Cancer Genetics Referral Screening Tool 3.0

Intervention Type OTHER

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).

Standard Handout

Intervention Type OTHER

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.

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.

Breast Cancer Genetics Referral Screening Tool 3.0

Intervention Type OTHER

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).

Standard Handout

Intervention Type OTHER

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.

Physician Notification

Intervention Type OTHER

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.

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.

Breast Cancer Genetics Referral Screening Tool 3.0

Intervention Type OTHER

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).

Standard Handout

Intervention Type OTHER

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.

Automatic Follow-Up by Genetic Counseling Staff

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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B-RST 3.0

Eligibility Criteria

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Inclusion Criteria

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