A Randomized Trial Comparing the Effectiveness of Pre-test Genetic Counseling Using an Artificial Intelligence Program and Traditional In-person Genetic Counseling in Women Newly Diagnosed With Breast Cancer Who do Not Currently Meet National Comprehensive Cancer Network (NCCN) Criteria for Genetic Testing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall comprehension as assessed by BCGCKQ
研究概览
简要总结
The purpose of this study is to help better understand the uptake and impact of genetic testing for women diagnosed with breast cancer who do not meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing. By doing so, the research team will gain a better understanding of the clinical implications for offering genetic testing for all patients recently diagnosed with breast cancer versus only offering genetic testing to those meeting NCCN criteria.
By offering genetic counseling and genetic testing to all women recently diagnosed with breast cancer, there will be a shortage of genetic counselors. This study will also assess the feasibility of using artificial intelligence to assist in the genetic counseling process.
详细描述
This is a randomized trial comparing the effectiveness of pre-test genetic counseling using an artificial intelligence program and traditional in-person genetic counseling in women newly diagnosed with breast cancer who do not currently meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing.
The primary objectives of this study are:
- To determine up-take of testing for those who do not meet NCCN guidelines for genetic testing
- To assess overall patient satisfaction and comprehension in both groups
The secondary objectives of this study are:
- To assess mutation rate in the overall cohort
- Identify reasons for not pursuing genetic testing
- Identify any specific areas of improvement in satisfaction and comprehension
- Assess the impact of genetic testing on Time to Treatment in this cohort
- Develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with Stage 0-3 breast cancer.
- •Patients who do not satisfy current NCCN criteria for referral to a genetics counselor and genetics testing.
- •Must have the ability to understand and the willingness to sign a written informed consent document as well as complete the study questionnaires.
排除标准
- 未提供
研究组 & 干预措施
in-person genetic counseling
Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
干预措施: Satisfaction Survey (Other)
Artificial intelligence program
Will complete consult with the use of an artificial intelligence program Chatbot.
干预措施: Automated program (ChatBot) (Genetic)
Artificial intelligence program
Will complete consult with the use of an artificial intelligence program Chatbot.
干预措施: BCGCKQ Survey (Other)
Artificial intelligence program
Will complete consult with the use of an artificial intelligence program Chatbot.
干预措施: Satisfaction Survey (Other)
Artificial intelligence program
Will complete consult with the use of an artificial intelligence program Chatbot.
干预措施: Genetic testing (Device)
in-person genetic counseling
Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
干预措施: Genetics counselor (Genetic)
in-person genetic counseling
Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
干预措施: BCGCKQ Survey (Other)
in-person genetic counseling
Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
干预措施: Genetic testing (Device)
结局指标
主要结局
Overall comprehension as assessed by BCGCKQ
时间窗: 3 years
Comprehension as assessed by previously validated survey consisting of 27 questions, which are a blend of True or False and multiple choice questions. The scale ranges from to , with higher scores indicating more comprehension. Comprehension will be compared between groups with t-test or Wilcoxon rank sum test.
Mean overall patient satisfaction with decision about genetic testing: survey
时间窗: 2 years
Mean overall patient satisfaction with decision about genetic testing as assessed by survey. The survey is a previously validated six-question Likert scale based survey. The scale ranges from 6 to 30, with higher scores indicating more satisfaction. Satisfaction will be compared between groups with t-test or Wilcoxon rank sum test. Published data suggest that standard deviation on the satisfaction survey is 3. A 2 point difference in average satisfaction score between groups is considered to be relevant
Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing
时间窗: 2 years
Up-take of testing for those who do not meet NCCN guidelines for genetic testing
次要结局
- Percentage of overall cohort with mutation(2 years)
- Frequencies of most common reasons for not pursuing genetic testing(2 years)
- Number of patients who decline genetic testing(2 years)
- Time to treatment(3 years)