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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial intelligence program | Experimental | Will complete consult with the use of an artificial intelligence program Chatbot. |
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| in-person genetic counseling | Active Comparator | Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated program (ChatBot) | Genetic | Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Number of patients who decline genetic testing |
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Inclusion Criteria:
Exclusion Criteria:
- N/A
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| Name | Affiliation | Role |
|---|---|---|
| Zahraa Al-Hilli, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
Commercially available software being used to conduct the study
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Genetics counselor | Genetic | Traditional in-person genetic counseling |
|
| BCGCKQ Survey | Other | Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ) |
|
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| Satisfaction Survey | Other | Survey assessing satisfaction with Decision-Genetic Testing |
|
| Genetic testing | Device | 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. |
|
Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test
| 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 | 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. | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |