Efficacy of Point Of Service Testing in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
研究概览
简要总结
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
- •Able to speak and read in the English language.
- •Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
- •Participants must be enrolled in the parent registry study.
排除标准
- •Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
- •Psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Point of service delivery model
After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model.
干预措施: Point of service delivery model (Other)
结局指标
主要结局
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
时间窗: 24 months
Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.
次要结局
- Clinical decisional conflict score(24 months)
- Overall participant satisfaction(24 months)
- Overall participant anxiety(24 months)