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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different methods of providing genetic testing information to cancer patients. It compares patient responses to a computer-generated character, the Patient-facing Relational Agent (PERLA), with those to a human healthcare provider for pre-test education. The goal is to improve access to genetic testing, particularly for individuals in rural areas or from minority groups. Those diagnosed with specific types of cancer, such as ovarian, pancreatic, or certain breast cancers, who can read English or Spanish, might be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative methods of delivering healthcare information.

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 the Patient-facing Relational Agent (PERLA) is safe for providing genetic testing education?

Research has shown that chatbots like the Patient-facing Relational Agent (PERLA) are generally safe for use in healthcare. Users of these digital tools often feel less worried, gain more knowledge, and better understand their health information. These chatbots are well-received, with no major reports of negative effects.

The study aims to determine if PERLA can enhance patients' understanding of genetic testing compared to usual care. This could be particularly beneficial for patients without easy access to genetic counseling. Although no specific safety issues have been identified with PERLA, discussing any concerns or questions with a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve access to genetic testing for cancer patients. Unlike the standard genetic counseling which relies solely on provider-based sessions before and after testing, the Patient-facing Relational Agent (PERLA) offers an educational component before testing, using a digital platform to enhance understanding. This approach could make genetic testing more accessible and less intimidating, potentially leading to better outcomes by empowering patients with knowledge. By comparing PERLA with usual care, researchers hope to discover if this hybrid method enhances patient experience and understanding.

What evidence suggests that the PERLA intervention is effective for improving access to genetic testing in cancer patients?

Research has shown that the Patient-facing Relational Agent (PERLA), which participants in this trial may receive, can help cancer patients access genetic testing more easily. PERLA is a digital program that provides information about genetic testing, simplifying patients' understanding of their options. Studies have found that technology like PERLA can help overcome obstacles to genetic testing, especially for people in underserved or rural areas. This method aims to increase the number of patients who complete recommended genetic testing. Although researchers are still studying PERLA's success in improving access, early signs suggest it could be a helpful tool in making genetic testing more available. ^{3 5 6 7 8}

Who Is on the Research Team?

Charite Ricker, MS

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. dana-farber.org dana-farber.org/clinical-trials/25-011

Increasing Access to Genetic Testing in Underserved ... This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-02187

Access to Genetic Testing in Underserved Patients with ... This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive ...

3. withpower.com withpower.com/trial/phase-carcinoma-6-2024-639f8

Genetic Testing Access for Cancer This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive ...

4. son.rochester.edu son.rochester.edu/newsroom/2024/closing-gaps-in-cancer-genetics.html

Closing Gaps in Cancer Genetics: UR Nursing Researcher ... Titled the Patient-Facing Educational and Relational Agent (PERLA), the digital program will provide automated pre-test education on cancer ...

5. ancora.ai ancora.ai/en/details/NCT06422455

Access to Genetic Testing in Underserved Patients With ... This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06422455

Study Details | NCT06422455 | Access to Genetic Testing ... This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/488041

Access to Genetic Testing in Underserved Patients With ... This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12043037/

Call to action for genetic counseling research in hereditary ... (2024) identified data to support that pre‐test genetic counseling significantly decreased worry, increased knowledge, and decreased perceived ...