Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Genetic: Genetics counselorGenetic: Automated program (ChatBot)Other: BCGCKQ SurveyOther: Satisfaction SurveyDevice: Genetic testing
- Registration Number
- NCT04354675
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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:
1. To determine up-take of testing for those who do not meet NCCN guidelines for genetic testing
2. To assess overall patient satisfaction and comprehension in both groups
The secondary objectives of this study are:
1. To assess mutation rate in the overall cohort
2. Identify reasons for not pursuing genetic testing
3. Identify any specific areas of improvement in satisfaction and comprehension
4. Assess the impact of genetic testing on Time to Treatment in this cohort
5. Develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 35
- 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.
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description in-person genetic counseling Genetics counselor Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor in-person genetic counseling BCGCKQ Survey Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor Artificial intelligence program BCGCKQ Survey Will complete consult with the use of an artificial intelligence program Chatbot. Artificial intelligence program Satisfaction Survey Will complete consult with the use of an artificial intelligence program Chatbot. in-person genetic counseling Genetic testing Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor Artificial intelligence program Automated program (ChatBot) Will complete consult with the use of an artificial intelligence program Chatbot. Artificial intelligence program Genetic testing Will complete consult with the use of an artificial intelligence program Chatbot. in-person genetic counseling Satisfaction Survey Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
- Primary Outcome Measures
Name Time Method Overall comprehension as assessed by BCGCKQ 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 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 relevantPercent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing 2 years Up-take of testing for those who do not meet NCCN guidelines for genetic testing
- Secondary Outcome Measures
Name Time Method Percentage of overall cohort with mutation 2 years Mutation rate as described by percentage of overall cohort with mutation. Groups will be compared with Chi-square test or Fisher's exact test
Frequencies of most common reasons for not pursuing genetic testing 2 years Reasons for not pursuing genetic testing in those who declined will be collected as a descriptive measure and then analyzed as frequencies of the different responses, summarizing the most common answers
Number of patients who decline genetic testing 2 years Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test
Time to treatment 3 years Time to treatment will be compared between patients who had genetic testing to those who did not using t-test or Wilcoxon rank sum test among all study patients.
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States