Strategies to Increase the Identification, Genetic Counseling Referral and Genetic Testing for Women at Risk for Hereditary Breast and/or Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 665
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient at one of the participating clinics (Winship Cancer Institute and Emory University Hospital Midtown) who arrive for a screening mammogram appointment.
排除标准
- •Patients receiving a diagnostic mammogram will not be invited to participate in the study.
结局指标
主要结局
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
时间窗: 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
时间窗: 18 Months from Baseline
次要结局
- 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)
研究者
Cecelia Bellcross
Assistant Professor
Emory University