Chatbot for Hereditary Cancer Risk Assessment

Recruiting at 3 trial locations

Overseen By Julia Cron, MD, FACOG

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Under 18, Prior genetic testing, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI Chatbot designed to identify individuals who might benefit from genetic testing for hereditary cancer. The chatbot communicates through text messages, gathers personal and family cancer history, and determines eligibility for genetic testing. The trial compares this method to the traditional approach, where a doctor collects this information during a visit. It seeks participants who are new patients at a gynecology clinic, have not previously undergone genetic testing for hereditary cancer, can speak and read English, and possess a texting-capable phone. As an unphased study, this trial provides a unique opportunity to explore innovative technology in healthcare.

Will I have to stop taking my current medications?

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

What prior data suggests that this chatbot is safe for hereditary cancer risk assessment?

Research shows that chatbots have assisted with genetic cancer risk assessments and counseling, making these services more accessible. While much attention focuses on how chatbots improve access and completion rates, their safety remains crucial.

Studies have not identified any major safety issues with chatbots for cancer risk assessment. These digital tools gather information and guide participants through the process effectively. Past trials using chatbots for genetic counseling reported no serious problems, suggesting that chatbots are safe and well-received in these contexts.

Prospective participants can feel reassured that chatbots have been used safely in similar studies. They enhance the efficiency of genetic counseling without compromising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using a chatbot to assess hereditary cancer risk, which is a fresh approach compared to traditional face-to-face consultations. Unlike standard care where clinicians collect and evaluate cancer history during visits, this chatbot leverages natural language processing to identify individuals who meet high-risk criteria for hereditary cancers. This approach could streamline the process, making it more efficient by providing pre-test genetic counseling and alerting clinicians when a person is at high risk, potentially leading to quicker interventions. The use of technology in this way could make cancer risk assessment more accessible and convenient, ultimately enhancing early detection and prevention strategies.

What evidence suggests that this chatbot is effective for hereditary cancer risk assessment?

Research has shown that chatbots can simplify the assessment and understanding of genetic cancer risks. In this trial, one group of participants will use a chatbot to complete their genetic cancer risk assessments. One study found that about 36.7% of people completed their assessments using chatbots. These chatbots help remove barriers to accessing genetic services, making it easier for patients to obtain necessary information. By using artificial intelligence, they interact with patients and gather details about personal and family cancer history, potentially leading to more recommendations for genetic testing. These early findings suggest that chatbots could be a valuable tool in managing hereditary cancer risk. ^{1 2 3 4 6}

Who Is on the Research Team?

Melissa K Frey, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older who are new patients at a gynecology clinic, speak and read English, and have access to text messaging on a phone. They should not have had genetic testing for hereditary cancer syndromes before.

Inclusion Criteria

Scheduled for a New Patient appointment in the gynecology clinic

Speaks and reads in English

Access to a telephone with texting capacity

Exclusion Criteria

I have undergone genetic testing for cancer syndromes.

Does not have access to a phone with texting capabilities

I cannot read or speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the chatbot intervention or usual care to assess genetic risk and facilitate genetic testing

2 years

Follow-up

Participants are monitored for the utilization of genetic testing services and barriers to testing

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Chatbot

Trial Overview The study tests if a chatbot using artificial intelligence can increase recommendations for genetic testing in patients at high risk of familial cancer syndromes compared to the usual care in an all-Medicaid gynecology clinic.

How Is the Trial Designed?

Group I: Chatbot Experimental Treatment 1 Intervention

Subjects will receive a text message initiating a chatbot conversation that relies on natural language processing to gather personal and family cancer. Subjects are identified by the chatbot as meeting National Comprehensive Cancer Network (NCCN) high-risk criteria. Next, subjects undergo pre-test genetic counseling via the chatbot and then clinicians are notified (via the chatbot portal) that the subject meets high-risk criteria. For subjects meeting high-risk criteria (based on the chatbot evaluation), the clinician will complete genetic counseling and recommend genetic testing during the visit. For subjects interested in genetic testing, the clinician will order genetic testing.

Group II: Usual Care Active Control 1 Intervention

Personal and family cancer history will be collected by the clinician during the subject's visit. Clinicians will evaluate the patient's personal/family history according to National Comprehensive Cancer Network (NCCN) high-risk criteria. For subjects recognized by the clinician as meeting NCCN criteria, the clinician will complete genetic counseling and recommend genetic testing. For subjects interested in genetic testing, the clinician will order genetic testing.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

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 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]

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]

A qualitative study involving 30 participants revealed that while chatbots are seen as useful for moderately complex tasks in the genetic testing process, they are considered inefficient for very simple or very complex tasks.

Participants expressed a preference for chatbots to complement traditional care rather than replace it, emphasizing the need for access to a clinician as a 'safety net' for more complex inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. Luca, S., Clausen, M., Shaw, A., 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]

The web-based chatbot ItRunsInMyFamily successfully engaged 14,140 users during a campaign, with 3,204 completing a full family health history assessment, indicating strong interest in hereditary cancer awareness.

The tool identified a wide range of cancers reported by users and their families, highlighting the potential for population-level data collection on family health history and the need for further enhancements to improve user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Chatbot to Assess Hereditary Cancer Risk. Welch, BM., Allen, CG., Ritchie, JB., et al.[2022]

The study demonstrated that using an AI-based chatbot to screen for hereditary colorectal cancer (HCRC) risk factors was feasible, with 11.9% of patients initiating the chat and 96.2% completing it, indicating strong engagement.

Of the participants who screened positive for HCRC risk, 71.3% consented to genetic testing, and 9.3% were found to have a germline pathogenic variant, highlighting the chatbot's potential to enhance genetic screening and identify at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using chatbots to screen for heritable cancer syndromes in patients undergoing routine colonoscopy. Heald, B., Keel, E., Marquard, J., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37934933/

Chatbot Artificial Intelligence for Genetic Cancer Risk ... The pooled estimated completion rate for the genetic cancer risk assessment was 36.7% (95% CI, 14.8 to 65.9). Two studies included comprehensive patient ...

2. ascopubs.org ascopubs.org/doi/10.1200/CCI.23.00123

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05562778

Chatbot to Maximize Hereditary Cancer Genetic Risk ... In this study, the investigators aim to compare a mobile health platform, known as a 'chatbot,' that leverages artificial intelligence and natural language ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823183

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 ...

5. cancer.jmir.org cancer.jmir.org/2025/1/e65848

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. labcorp.com labcorp.com/education-events/articles/precision-medicine-and-future-healthcare-four-benefits-ai-chatbots-genetic-testing

Four benefits of AI chatbots in genetic testing Chatbot-driven genetic screening programs achieve high completion rates, with one study showing 82.3% of patients completing their initial ...