BRCA Founder OutReach (BFOR) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,412
- 试验地点
- 5
- 主要终点
- Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
研究概览
简要总结
The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported age ≥ 25
- •Self identify as having at least one of their four grandparents as Ashkenazi Jewish
- •Has medical insurance
- •Able to understand and read the English-language
- •Zip code falls within the catchment areas of the phase of the study (e.g. New York City, Boston, Philadelphia, Los Angeles) accessible to a BFOR designated provider
排除标准
- •Under age 25
- •No Ashkenazi Jewish ancestry
- •Does not have insurance
- •Has previously had medical BRCA testing ordered by a health care provider
研究组 & 干预措施
Participants with Ashkenazi ancestry
干预措施: BFOR Digital Health solution/Web Portal (Other)
结局指标
主要结局
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
时间窗: Up to 1 year
Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process
时间窗: Up to 1 year
Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process
Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication
时间窗: Up to 1 year
Written survey for health and diagnostic updates
Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff
时间窗: Up to 1 year
Psychosocial impact of genetic population screening utilizing a digital health solution
时间窗: Up to 1 year
Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.
次要结局
未报告次要终点