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

Disqualifiers: None

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different methods of providing genetic counseling for women recently diagnosed with breast cancer. It compares an artificial intelligence (AI) chatbot (an automated program) with traditional in-person counseling to determine which is more effective and practical, particularly for those who don't qualify for genetic testing under current guidelines. The goal is to assess whether offering genetic testing to all women with breast cancer can aid in their treatment. Women with stage 0-3 breast cancer who don't meet current genetic testing criteria might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in genetic counseling that could benefit future patients.

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 prior data suggests that this genetic counseling method is safe?

Research has shown that using chatbots for genetic counseling is generally safe and well-received. Studies have found that these AI tools can help people understand their genetic risk for cancer. Although specific information on side effects is limited, chatbots have been used successfully in genetic counseling without any major negative effects reported.

In-person genetic counseling is a well-established and safe process. Genetic counselors are trained to provide information and support, and this method has been standard practice for many years.

Overall, both AI chatbots and in-person counseling are designed to help patients understand their genetic risks safely, without significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of a cutting-edge AI-driven ChatBot to provide genetic counseling for breast cancer. Unlike traditional in-person sessions with a genetics counselor, the AI ChatBot offers a flexible and accessible approach, allowing patients to receive counseling anytime and anywhere. This technology can potentially reduce wait times and increase access to genetic counseling, especially in areas with a shortage of professionals. By harnessing advanced algorithms, the AI ChatBot aims to deliver personalized and efficient consultations, making genetic counseling more scalable and potentially transforming how patients receive this important information.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the effectiveness of an AI Chatbot with traditional in-person genetic counseling for breast cancer patients. Research has shown that using an AI Chatbot for genetic counseling can be as effective as meeting with a counselor in person. In one study, patients who used the Chatbot felt as satisfied and informed as those who spoke with a genetic counselor. Another study found that both the Chatbot and traditional counseling led to similar rates of completing pre-test genetic services. This suggests that AI Chatbots can simplify the process and increase access to genetic counseling, which is promising for making these services available to more patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Zahraa Al-Hilli, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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A Randomized Trial Comparing the Effectiveness of Pre- ... Conclusion: Satisfaction and comprehension in patients with breast cancer undergoing pre-test genetic counseling using an automated Chatbot is ...

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Uptake of Cancer Genetic Services for Chatbot vs Standard ... This randomized clinical trial examines whether chatbot and standard-of-care delivery models are equivalent in completion of pretest cancer ...

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Chatbot Artificial Intelligence for Genetic Cancer Risk ... Chatbots have been used to streamline genetic cancer risk assessment and counseling and hold promise for reducing barriers to genetic services.

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Evaluation of the digital genetic assistant in technology ... In this study, we evaluated the clinical utility of the DGA as well as its ability to streamline the genetic counseling workflow and gauge ...

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Chatbot for the Return of Positive Genetic Screening Results ... This project aimed to design, implement, and evaluate a chatbot integrated with GPT-4, tailored to support the return of positive genomic screening results.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548301/

Patients' and healthcare professionals' experiences with ... The aim of this study is to explore how newly diagnosed patients with breast or ovarian cancer and healthcare professionals' (HCPs) experience ...

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Uptake of Cancer Genetic Services for Chatbot vs Standard ... For the primary outcome of completion of pretest cancer genetic services, the estimated percentage point difference between groups was 2.0 (95% CI, −1.1 to 5.0 ...

8. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-23488-4

Implementing a chatbot to promote hereditary breast & ovarian ... While chatbots can extend women's cancer risk screening access, particularly in rural regions and with college-educated women, systems-level ( ...