Genetic Counseling Methods for Cancer Risk

Overseen By Joseph Petruzziello

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Non-English/Spanish speakers, Prior genetic testing

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

Compensation: Varies

Number of Visits: 1

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different methods of providing genetic screening for cancer risk in rural communities. It compares the effectiveness of two approaches: pre-genetic test counseling through a chatbot named GIA (Genetic Information Assistant) and sessions with a genetic counselor. The trial aims to determine which method encourages more individuals to undergo genetic testing. Suitable participants are those at high risk for certain cancers, have not previously completed genetic testing, and can access the internet on a smartphone or computer. As an unphased study, this trial offers participants the chance to contribute to innovative approaches in genetic screening, potentially improving access to vital health information in rural areas.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these genetic counseling methods are safe?

Research has shown that chatbots like the Genetic Information Assistant (GIA) are generally safe and easy to use for genetic counseling. One study found that chatbots help assess genetic cancer risk and provide counseling, making genetic services more accessible, especially in remote areas.

No major reports of negative reactions have emerged from using these chatbots. They are designed to be user-friendly and secure, adhering to health information privacy laws. Other studies have demonstrated that chatbots can effectively educate patients about genetic risks, proving their usefulness in healthcare.

Overall, current research considers the use of the GIA chatbot in genetic counseling safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new way of delivering genetic counseling for cancer risk. Unlike the standard approach, which involves a one-on-one session with a genetic counselor, this trial is testing a chatbot called the Genetic Information Assistant (GIA) for delivering pre-test counseling. This method could make genetic counseling more accessible and convenient for people by providing immediate and consistent information without needing to schedule an appointment. If successful, it could revolutionize how genetic counseling is provided, potentially reaching a wider audience and reducing the demand on human resources.

What evidence suggests that these genetic counseling methods are effective for increasing genetic testing uptake in rural communities?

Research has shown that chatbots, such as the Genetic Information Assistant (GIA) available to participants in this trial, can aid in genetic counseling. One study found that the chatbot identified three times more patients with high-risk genetic traits than traditional methods. Another study showed that the chatbot completed genetic cancer risk assessments at a rate of about 36.7%. Additionally, the chatbot proved more cost-effective in identifying high-risk patients. These findings suggest that using a chatbot for genetic counseling could be a promising option for individuals at risk of certain cancers. ^{1 2 5 6 7}

Who Is on the Research Team?

Kari L. Ring

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults over 18 at high risk for certain cancers based on NCCN guidelines, who have a smartphone or computer with internet and can use it well. They must agree to all study procedures and be available throughout the study.

Inclusion Criteria

Participants must possess a smartphone enabled with cellular and/or internet capabilities, or have access to a computer connected to the web.

I am at high risk for a genetic mutation based on guidelines.

Participants must demonstrate technological savvy to effectively utilize their Smartphone and/or computer with the GIA communication aid.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test Counseling

Participants receive pre-genetic test counseling via either a genetic counselor or the GIA chatbot

1-2 weeks

1 visit (virtual or phone)

Genetic Testing

Participants provide a saliva sample for genetic testing and receive their results

3 months

Follow-up

Participants are monitored for outcomes related to financial toxicity, cancer knowledge, and decisional conflict

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Information Assistant

Trial Overview

The trial is testing if pre-test genetic counseling via a chatbot (GIA) or by a human counselor affects participants' decisions to undergo genetic testing. It involves sessions, questionnaires, saliva samples for gene mutation tests, result discussions, and optional family sharing.

How Is the Trial Designed?

Group I: Novel interventional arm of pre-test counseling via GIA Experimental Treatment 1 Intervention

Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA)

Group II: Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling Active Control 1 Intervention

Pre-genetic test counselling with a genetic counselor from the University of Virginia

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

A feasibility study involving 60 pancreatic cancer patients showed that an educational chatbot about genetic testing was well-received, with 80% of participants engaging with it and 71% completing surveys.

Patients who opted for genetic testing interacted more with the chatbot, suggesting that providing education through this method may help reduce decisional conflict and encourage testing adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Genetic Information Assistant Chatbot to Provide Genetic Education and Study Genetic Test Adoption Among Pancreatic Cancer Patients at Johns Hopkins Hospital. Soley, N., Klein, A., Taylor, CO., 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]

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]

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]

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]

Genetic counsellors found the REACT software effective in aiding communication about cancer risk, indicating it could enhance the counselling process for patients.

However, there were concerns about how the software might affect the dynamics of consultations, suggesting that new counselling skills may be needed to integrate it effectively into practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive decision support for risk management: a qualitative evaluation in cancer genetic counselling sessions. Glasspool, DW., Oettinger, A., Braithwaite, D., et al.[2021]

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]

Citations

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ascopubs.org

ascopubs.org/doi/10.1200/CCI.23.00123

Chatbot Artificial Intelligence for Genetic Cancer Risk ...

The pooled estimated completion rate for the genetic cancer risk assessment portion of the chatbot was 36.7%. Although data were limited, ...

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invitae.com/us/providers/gia-chatbot

Invitae Gia® chatbot: Genetic information assistant

A HIPAA-compliant clinical chatbot, Gia facilitates virtual conversations with patients, including intake of family history and automatic delivery of results.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10283105/

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We completed a feasibility assessment of a chatbot to provide genetic education (GEd) with 60 pancreatic cancer patients and using the chatbot to deliver ...

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jamanetwork.com

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This randomized clinical trial examines whether chatbot and standard-of-care delivery models are equivalent in completion of pretest cancer ...

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healio.com

healio.com/news/hematology-oncology/20230330/chatbot-more-costeffective-for-finding-highrisk-pathogenic-variants-in-cancer-genes

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The chatbot identified three times as many patients with high-risk pathogenic variants as a traditional genetic counseling pathway.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11385050/

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 ...

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bmcpublichealth.biomedcentral.com

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

Implementing a chatbot to promote hereditary breast & ovarian ...

Chatbots like the Genetic Information Assistant (Gia®) are increasingly implemented to expand access to hereditary genetic screening. Factors ...