Genetic Testing Access for Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Charite Ricker, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

Disqualifiers: Cannot consent, Cannot read/write, Others

No Placebo Group

Trial Summary

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.

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}

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

Trial 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) (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

USC / Norris Comprehensive Cancer Center Los Angeles, CA

University of Rochester Rochester, NY

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

National Cancer Institute (NCI) Collaborator

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] Genetic testing is a valuable tool to guide care of pancreatic cancer patients, yet personal and family uncertainty about the benefits of genetic testing (i.e., decisional conflict) may lead to low adoption. Enabling patients to learn more about genetic testing before their scheduled appointments may help to address this decisional conflict problem. We completed a feasibility assessment of a chatbot to provide genetic education (GEd) with 60 pancreatic cancer patients and using the chatbot to deliver surveys to assess: (a) opinions about the GEd, and (b) decisional conflict about genetic testing. Findings demonstrate intervention and study feasibility with about 80% of participants engaging with the GEd chatbot, 71% of which completed at least one survey. Overall, participants appear to have favorable opinions of the chatbot-delivered education and thought it was helpful to decide about genetic testing. Furthermore, patients who chose to get genetic testing spent more time interacting with the chatbot. Findings will be used to improve chatbot design and to facilitate a well-powered future trial.

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

Interventions to improve delivery of cancer genetics services in the United States: A scoping review. [2022] Interventions that decrease barriers and improve clinical processes can increase patient access to guideline-recommended cancer genetics services. We sought to identify and describe interventions to improve patient receipt of guideline-recommended cancer genetics services in the United States.

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

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study. [2023] Cancer genetic testing to assess an individual's cancer risk and to enable genomics-informed cancer treatment has grown exponentially in the past decade. Because of this continued growth and a shortage of health care workers, there is a need for automated strategies that provide high-quality genetics services to patients to reduce the clinical demand for genetics providers. Conversational agents have shown promise in managing mental health, pain, and other chronic conditions and are increasingly being used in cancer genetic services. However, research on how patients interact with these agents to satisfy their information needs is limited.

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

Democratizing genomics: Leveraging software to make genetics an integral part of routine care. [2021] Genetic testing can provide definitive molecular diagnoses and guide clinical management decisions from preconception through adulthood. Innovative solutions for scaling clinical genomics services are necessary if they are to transition from a niche specialty to a routine part of patient care. The expertise of specialists, like genetic counselors and medical geneticists, has traditionally been relied upon to facilitate testing and follow-up, and while ideal, this approach is limited in its ability to integrate genetics into primary care. As individuals, payors, and providers increasingly realize the value of genetics in mainstream medicine, several implementation challenges need to be overcome. These include electronic health record integration, patient and provider education, tools to stay abreast of guidelines, and simplification of the test ordering process. Currently, no single platform offers a holistic view of genetic testing that streamlines the entire process across specialties that begins with identifying at-risk patients in mainstream care settings, providing pretest education, facilitating consent and test ordering, and following up as a "genetic companion" for ongoing management. We describe our vision for using software that includes clinical-grade chatbots and decision support tools, with direct access to genetic counselors and pharmacists within a modular, integrated, end-to-end testing journey.

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

Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. [2023] Chatbots, web-based artificial intelligence tools that simulate human conversation, are increasingly in use to support many areas of genomic medicine. However, patient preferences towards using chatbots across the range of clinical settings are unknown. We conducted a qualitative study with individuals who underwent genetic testing for themselves or their child. Participants were asked about their preferences for using a chatbot within the genetic testing journey. Thematic analysis employing interpretive description was used. We interviewed 30 participants (67% female, 50% 50 + years). Participants considered chatbots to be inefficient for very simple tasks (e.g., answering FAQs) or very complex tasks (e.g., explaining results). Chatbots were acceptable for moderately complex tasks where participants perceived a favorable return on their investment of time and energy. In addition to achieving this "sweet spot," participants anticipated that their comfort with chatbots would increase if the chatbot was used as a complement to but not a replacement for usual care. Participants wanted a "safety net" (i.e., access to a clinician) for needs not addressed by the chatbot. This study provides timely insights into patients' comfort with and perceived limitations of chatbots for genomic medicine and can inform their implementation in practice.

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

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. [2023] To examine user uptake and experience with a clinical chatbot that automates hereditary cancer risk triage by collecting personal and family cancer history in routine women's health care settings.