Genetic Counseling Methods for Cancer Risk

Overseen By Magnifique Irakoze

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

Trial Summary

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 data supports the effectiveness of the treatment Genetic Information Assistant Chatbot for cancer risk counseling?

Research shows that chatbots can effectively engage patients in genetic education, with about 80% of pancreatic cancer patients interacting with the chatbot and finding it helpful for decision-making about genetic testing. Additionally, chatbots are seen as useful for moderately complex tasks in genetic services, suggesting they can be a valuable tool in cancer risk counseling. ^{1 2 3 4 5}

Is the Genetic Information Assistant Chatbot safe for use in humans?

The Genetic Information Assistant Chatbot has been used in studies with participants for genetic counseling and education, and no safety concerns have been reported. Participants generally found the chatbot helpful and user-friendly for learning about genetic testing and sharing information with relatives. ^{2 3 4 5 6}

How is the Genetic Information Assistant (GIA) treatment different from other treatments for cancer risk assessment?

The Genetic Information Assistant (GIA) is unique because it uses a chatbot to automate the process of assessing hereditary cancer risk by collecting personal and family cancer history. This approach allows for a self-paced, private, and informative experience, which can be more convenient and less embarrassing for users compared to traditional face-to-face genetic counseling. ^{2 3 5 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is: • Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing? Participants will: * have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot * answer questions about their cancer genetic knowledge and how they are doing * provide a saliva sample for genetic testing to test for cancer gene mutations * have their genetic testing results provided to them. * have the option to share their genetic testing results with family members Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.

Research Team

Kari L. Ring

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. [2023]

2. 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]

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

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

4. United States 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. [2023]

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

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

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

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

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

Using a Chatbot to Assess Hereditary Cancer Risk. [2022]

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

Interactive decision support for risk management: a qualitative evaluation in cancer genetic counselling sessions. [2021]