Clinical trial NCT02786147: Identification and Referral of Women at Risk for Hereditary Breast/Ovarian Cancer
Official title: Strategies to Increase the Identification, Genetic Counseling Referral and Genetic Testing for Women at Risk for Hereditary Breast and/or Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Breast and Ovarian Cancer
Keywords: Breast Cancer
Ovarian Cancer
B-RST
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 665
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female adult patients of the Winship Cancer Institute or Emory University Hospital Midtown that arrive for screening (non-diagnostic) mammogram appointments will be selected will be invited for participation.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 18 Months from Baseline
measure: Number of participants who complete cancer genetic counseling after Self-Referral, Physician Notification by EeMR, Direct Contact by Cancer Genetics Program
timeFrame: 18 Months from Baseline
Secondary outcomes:
measure: Number of participants who underwent genetic testing after genetic counseling
timeFrame: 18 Months from Baseline
measure: Number of participants who were identified with a BRCA1/2 mutation
timeFrame: 18 Months from Baseline
measure: Number of participants who were identified with a mutation in a different hereditary cancer gene
timeFrame: 18 Months from Baseline
measure: Number of participants who were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services
timeFrame: 18 Months from Baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Cecelia Bellcross, PhD, MS, CGC
role: PRINCIPAL_INVESTIGATOR
References: