An interventional study of Automated program (ChatBot) and Genetics counselor in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Screening
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.
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:
The secondary objectives of this study are:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- N/A
Will complete consult with the use of an artificial intelligence program Chatbot.
Genetic: Automated program (ChatBot) · Other: BCGCKQ Survey · Other: Satisfaction Survey · Device: Genetic testing
Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor
Genetic: Genetics counselor · Other: BCGCKQ Survey · Other: Satisfaction Survey · Device: Genetic testing
Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)
Traditional in-person genetic counseling
Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
Also known as: Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
Survey assessing satisfaction with Decision-Genetic Testing
Genetic testing for all participants will assess for a mutation in 47 genes commonly associated with hereditary cancer syndromes (Invitae's Common Hereditary Cancer Panel) for those who choose to complete testing.
Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing
Up-take of testing for those who do not meet NCCN guidelines for genetic testing
Time frame: 2 years
Mean overall patient satisfaction with decision about genetic testing: survey
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
Time frame: 2 years
Overall comprehension as assessed by BCGCKQ
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.
Time frame: 3 years
Percentage of overall cohort with mutation
Mutation rate as described by percentage of overall cohort with mutation. Groups will be compared with Chi-square test or Fisher's exact test
Time frame: 2 years
Number of patients who decline genetic testing
Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test
Time frame: 2 years
Frequencies of most common reasons for not pursuing genetic testing
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
Time frame: 2 years
Time to treatment
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.
Time frame: 3 years
Plan to share: No — Commercially available software being used to conduct the study
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center