Genetic Testing Access for Cancer

Recruiting at 1 trial location

Overseen By Charite Ricker, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Cannot consent, Cannot read/write, Others

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

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Patient-facing Relational Agent (PERLA) for Genetic Testing Access for Cancer?

Research shows that chatbots, like PERLA, can help patients understand genetic testing and reduce uncertainty about its benefits. In a study with pancreatic cancer patients, 80% engaged with a genetic education chatbot, and those who spent more time with it were more likely to choose genetic testing. ^{1 2 3 4 5}

Is the Patient-facing Relational Agent (PERLA) safe for use in genetic testing for cancer?

The research indicates that chatbots, like PERLA, are generally considered safe and acceptable for providing genetic education and support in cancer genetic services. Participants found them helpful for making decisions about genetic testing, and they are increasingly used to manage various health conditions. ^{1 3 4 5 6}

How is the treatment Patient-facing Relational Agent (PERLA) different from other treatments for cancer?

PERLA is unique because it uses a chatbot to provide genetic education and support decision-making about genetic testing, which can help patients understand their cancer risk and treatment options. This approach is novel as it automates the process, making genetic services more accessible and reducing the demand on healthcare providers. ^{1 3 4 5 6}

What is the purpose of this trial?

This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial/ethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care.

Research Team

Charite Ricker, MS

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for cancer patients who might benefit from genetic testing but have limited access to it, especially those in racial/ethnic minorities or living in rural areas. Participants should be treated at hospitals with few genetics services and must speak either English or Spanish.

Inclusion Criteria

I am older than 18 years.

Able to read and write in English or Spanish

I have been diagnosed with a specific type of cancer or treat patients with these cancers.

Exclusion Criteria

Healthcare provider who do not treat cancer patients

I am unable to give informed consent.

Patients who cannot see, read, or write

Timeline

Development

Participants attend focus groups and provide feedback on the content, format, and usability of the PERLAs to tailor the design of the intervention.

Not specified

Usability

Participants attend usability testing and provide feedback through cognitive interviews.

Not specified

Pilot Testing

Participants evaluate the newly developed PERLAs and provide feedback through focused interviews and structured assessment.

Not specified

Intervention

Patients are randomized to receive either PERLA or usual care for pre- and post-test genetic counseling.

20-60 minutes

Implementation

Participants complete qualitative interviews to evaluate potential barriers and facilitators to implementation of PERLA in the clinic.

Not specified

Follow-up

Participants are monitored for outcomes at 1, 3, and 6 months after completion of the study intervention.

6 months

Treatment Details

Interventions

• Patient-facing Relational Agent (PERLA)

Trial Overview The study compares two ways of educating about genetic testing: one uses a computer-generated character (PERLA) and the other uses human healthcare providers. It aims to see if PERLA can improve access to genetic testing for cancer patients.

Participant Groups

Group I: Intervention Phase Arm A (PERLA) Experimental Treatment 5 Interventions

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

Group II: Intervention Phase Arm B (usual care) Active Control 3 Interventions

Patients receive access to usual care pre- and post-test provider-based genetic counseling.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Findings from Research

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]

A review of 44 articles identified various interventions aimed at improving patient access to cancer genetics services in the U.S., focusing on areas like patient identification, referral, genetic counseling, and genetic testing.

Key strategies included universal tumor testing for identifying eligible patients, adaptations in medical record systems for referrals, and integrating genetic counseling within oncology clinics to enhance service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve delivery of cancer genetics services in the United States: A scoping review. Bednar, EM., Nitecki, R., Krause, KJ., et al.[2022]

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]

Genetic testing can significantly improve patient care by providing clear molecular diagnoses and guiding treatment decisions from preconception to adulthood, but it currently faces challenges in becoming a routine part of primary care.

To effectively integrate genetic testing into mainstream medicine, innovative solutions like software with clinical-grade chatbots and decision support tools are needed to streamline the testing process and enhance patient and provider education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Democratizing genomics: Leveraging software to make genetics an integral part of routine care. Snir, M., Nazareth, S., Simmons, E., et al.[2021]

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]

References

1. 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]

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

Interventions to improve delivery of cancer genetics services in the United States: A scoping review. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

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

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

Democratizing genomics: Leveraging software to make genetics an integral part of routine care. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

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