AI Genetic Counseling vs In-Person Genetic Counseling for Breast Cancer

Overseen By Zahraa Al-Hilli, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of AI Genetic Counseling vs In-Person Genetic Counseling for Breast Cancer?

Research shows that chatbots, which are automated programs that simulate conversation, can effectively provide genetic cancer risk assessment and counseling. Patients appreciated the self-paced, private, and informative nature of computer programs, which can help reduce the demand on genetic counselors by handling routine educational tasks. ^{1 2 3 4 5}

Is AI genetic counseling safe for humans?

Research shows that AI chatbots used for genetic counseling are generally safe and well-received by users. Participants in studies have found them to be user-friendly and acceptable for sharing genetic information and managing counseling tasks. ^{1 2 3 4 6}

How does AI genetic counseling differ from traditional genetic counseling for breast cancer?

AI genetic counseling uses chatbots (automated programs that simulate conversation) to provide genetic risk assessment and counseling, offering a more accessible and scalable alternative to traditional in-person sessions with a genetic counselor. This approach can help address the shortage of healthcare workers and meet the growing demand for genetic services. ^{1 2 7 8 9}

Research Team

Zahraa Al-Hilli, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for women recently diagnosed with Stage 0-3 breast cancer who don't meet the criteria for genetic testing as per NCCN guidelines. Participants must understand and be willing to sign a consent form and complete study questionnaires.

Inclusion Criteria

I do not meet the criteria for genetic counseling according to NCCN guidelines.

My breast cancer is at stage 0 to 3.

I can understand and am willing to sign the consent form and complete questionnaires.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Counseling

Participants receive genetic counseling either through an AI program or traditional in-person methods

4-6 weeks

1 visit (in-person or virtual)

Genetic Testing

Participants undergo genetic testing to assess mutation rates and other genetic factors

2-4 weeks

Follow-up

Participants are monitored for satisfaction, comprehension, and impact on time to treatment

3 years

Treatment Details

Interventions

• Automated program (ChatBot)
• Genetics counselor
• Genetic testing

Trial Overview The study compares traditional in-person genetic counseling with an AI-powered ChatBot program for patients. It aims to see if AI can help manage the increased demand for genetic counseling due to offering testing to all regardless of NCCN criteria.

Participant Groups

Group I: Artificial intelligence program Experimental Treatment 4 Interventions

Will complete consult with the use of an artificial intelligence program Chatbot.

Group II: in-person genetic counseling Active Control 4 Interventions

Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Chatbots have been evaluated in seven studies for their effectiveness in genetic cancer risk assessment and counseling, showing a pooled completion rate of 36.7% for risk assessments, indicating they can help streamline the process.

While chatbots show promise in making genetic services more accessible, there is a lack of comprehensive data on user characteristics and their effectiveness compared to traditional care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chatbot Artificial Intelligence for Genetic Cancer Risk Assessment and Counseling: A Systematic Review and Meta-Analysis. Webster, EM., Ahsan, MD., Perez, L., et al.[2023]

In a feasibility study involving 103 primary care patients eligible for cancer genetic evaluation, 70% of those who completed a chat with a conversational agent expressed a desire to proceed with genetic testing, indicating the agent's effectiveness in providing pretest education.

The study revealed that while most users found the information sufficient to make a decision, a subset of participants who were unsure about testing spent more time interacting with the agent and requested additional information, suggesting that some patients may still need more personalized support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study. Chavez-Yenter, D., Kimball, KE., Kohlmann, W., et al.[2023]

In a study involving 95,166 patients, 64.2% engaged with a clinical chatbot designed to assess hereditary cancer risk, with 89.4% completing the risk assessment, indicating high acceptability and usability of the tool.

The chatbot identified that 25% of users met the criteria for genetic testing for hereditary cancer syndromes, and among those tested, 5.6% had a pathogenic variant, demonstrating its effectiveness in triaging high-risk patients for further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. Nazareth, S., Hayward, L., Simmons, E., et al.[2023]

In a study involving 29 women at moderate risk for breast cancer, participants preferred genetic counselors for personal interactions, emotional support, and individualized decision-making during genetic education and counseling.

However, many participants appreciated the interactive computer program for its self-paced learning, privacy, and efficiency, suggesting that combining both methods could enhance the overall genetic counseling experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. Green, MJ., McInerney, AM., Biesecker, BB., et al.[2019]

A web-based educational tool significantly increased knowledge and feelings of empowerment regarding genetic testing among 305 patients, regardless of their health literacy levels, indicating its effectiveness in educating patients before genetic counseling.

The tool may help address the shortage of trained genetic providers by streamlining the delivery of genetic services, as it was shown to enhance patient understanding without altering attitudes towards testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. Cragun, D., Weidner, A., Tezak, A., et al.[2021]

Participants in focus groups found chatbots to be an engaging and acceptable method for consenting to genomic research and managing follow-up actions after receiving genetic results, indicating potential for broader use in healthcare.

Despite limited prior experience with chatbots, most participants expressed willingness to use them for sharing genetic information with relatives, suggesting that these technology-based tools could effectively facilitate communication in genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient assessment of chatbots for the scalable delivery of genetic counseling. Schmidlen, T., Schwartz, M., DiLoreto, K., et al.[2020]

Telephone genetic counseling for BRCA1 and BRCA2 testing is as effective as in-person counseling in terms of reducing cancer-specific distress and improving genetic knowledge, based on a systematic review of four studies.

This approach may provide a viable alternative for delivering genetic services, especially during situations like the COVID-19 pandemic, although more research is needed to confirm these findings across broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of telephone vs in-person genetic counseling in BRCA1/BRCA2 genetic testing. Bracke, X., Roberts, J., McVeigh, TP.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chatbot Artificial Intelligence for Genetic Cancer Risk Assessment and Counseling: A Systematic Review and Meta-Analysis. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Patient assessment of chatbots for the scalable delivery of genetic counseling. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations. [2018]

8. England pubmed.ncbi.nlm.nih.gov

DNA-testing for BRCA1/2 prior to genetic counselling in patients with breast cancer: design of an intervention study, DNA-direct. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of telephone vs in-person genetic counseling in BRCA1/BRCA2 genetic testing. [2021]