Breast CancerNCT04354675
Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer
A study testing Automated program (ChatBot), Genetics counselor and BCGCKQ Survey in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Automated program (ChatBot), Genetics counselor and BCGCKQ Survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: 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 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.
Read the 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:
- 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
- Conditions
- Breast Cancer
- Being tested
- Automated program (ChatBot), Genetics counselor, BCGCKQ Survey, Satisfaction Survey, Genetic testing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated program (ChatBot)Genetic
Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)
Genetics counselorGenetic
Traditional in-person genetic counseling
BCGCKQ SurveyOther
Also called Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
Satisfaction SurveyOther
Survey assessing satisfaction with Decision-Genetic Testing
Genetic testingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence program | Experimental | Will complete consult with the use of an artificial intelligence program Chatbot. Receives: Genetic: Automated program (ChatBot); Other: BCGCKQ Survey; Other: Satisfaction Survey; Device: Genetic testing |
| in-person genetic counseling | Active comparator | Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor Receives: Genetic: Genetics counselor; Other: BCGCKQ Survey; Other: Satisfaction Survey; Device: Genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 3 years
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start29 Jun 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zahraa Al-Hilli, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354675
- Sponsor's protocol ID
- CASE12119
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2020
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Commercially available software being used to conduct the study
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04354675
- Acronym / sponsor ID
- CASE12119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence program | Experimental | Genetic: Automated program (ChatBot), Other: BCGCKQ Survey, Other: Satisfaction Survey, Device: Genetic testingWill complete consult with the use of an artificial intelligence program Chatbot. |
| in-person genetic counseling | Active comparator | Genetic: Genetics counselor, Other: BCGCKQ Survey, Other: Satisfaction Survey, Device: Genetic testingWill complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated program (ChatBot)Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot) | Genetic | Artificial intelligence program |
| Genetics counselorTraditional in-person genetic counseling | Genetic | in-person genetic counseling |
| BCGCKQ SurveyAlso: Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ) | Other | Artificial intelligence program, in-person genetic counseling |
| Satisfaction SurveySurvey assessing satisfaction with Decision-Genetic Testing | Other | Artificial intelligence program, in-person genetic counseling |
| Genetic testingGenetic 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. | Device | Artificial intelligence program, in-person genetic counseling |
Primary outcome
Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing
Time frame: 2 years
Up-take of testing for those who do not meet NCCN guidelines for genetic testing
Mean overall patient satisfaction with decision about genetic testing: survey
Time frame: 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
Overall comprehension as assessed by BCGCKQ
Time frame: 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.
4 secondary outcomes
Percentage of overall cohort with mutation
Time frame: 2 years
Number of patients who decline genetic testing
Time frame: 2 years
Frequencies of most common reasons for not pursuing genetic testing
Time frame: 2 years
Time to treatment
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Commercially available software being used to conduct the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahraa Al-Hilli, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated program (ChatBot), Genetics counselor and BCGCKQ Survey in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.