Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06422455

Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent

Led by University of Southern California · Updated on 2026-03-18

800

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Southern California

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new way to provide genetic testing information to patients with cancer, comparing a computer-generated conversational agent called PERLA to usual care involving a human genetics healthcare provider. The study focuses on patients who may have limited access to genetic counseling, especially those from racial or ethnic minority groups and rural areas served by safety-net hospitals. The study aims to improve access to genetic testing, which is becoming standard care for many cancer patients, by using health information technology to offer education in both English and Spanish. The study includes several phases: development, usability testing, pilot testing, and an intervention phase. In the intervention phase, patients are randomly assigned to one of two groups. One group receives pre-test genetics education through PERLA followed by standard post-test counseling by a provider, while the other group receives usual care with both pre- and post-test counseling from a provider. The education sessions last between 20 and 60 minutes. After the intervention, participants complete interviews to identify barriers and facilitators to implementing PERLA in clinical settings. Participants attend focus groups, usability tests, and interviews throughout the study to provide feedback on PERLA's content and usability. They are followed up at 1, 3, and 6 months after the intervention. Researchers measure the proportion of patients who receive genetic test results within 3 months of starting cancer care and collect patient-reported outcomes during this period. The study also includes ancillary activities such as surveys, interviews, and electronic health record reviews to support the research goals.

CONDITIONS

Brief Title

Access to Genetic Testing in Underserved Patients With Cancer

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years old
  • Diagnosed with at least one of the following: epithelial ovarian cancer, exocrine pancreatic cancer, metastatic or high or very high-risk prostate cancer, breast cancer at or before age 50, bilateral breast cancer, triple negative breast cancer, or male breast cancer
  • Healthcare provider who treats patients with any of the above types of cancer
  • Able to read and write in English or Spanish
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Unable to see, read, or write
  • Have the listed cancer diagnoses but do not speak English or Spanish
  • Do not have any of the listed cancer diagnoses and clinical characteristics
  • Healthcare provider who does not treat cancer patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Development Phase

Duration - Not specified

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

Focus group sessions as scheduled

Usability Phase

Duration - Not specified

Participants attend usability testing and provide feedback through cognitive interviews on the English- and Spanish-language PERLAs.

1 to 2 visits for usability testing and interviews

Pilot Testing Phase

Duration - Not specified

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

1 to 2 visits for assessments and interviews

Intervention Phase

Duration - Up to 3 months

Participants are randomized to receive either pre-test genetics education via the PERLA and standard post-test provider-based genetic counseling or usual care pre- and post-test provider-based genetic counseling.

1 baseline visit and follow-up visits at 1, 3, and 6 months

Implementation Phase

Duration - Not specified

Participants complete qualitative interviews to evaluate potential barriers and facilitators to implementing PERLA in the clinical setting.

1 to 2 interviews after intervention completion

Follow-up

Duration - Up to 6 months post intervention

Participants are followed up to assess outcomes and acceptability at 1, 3, and 6 months after completing the intervention.

3 follow-up visits

Trial Site Locations

Total: 2 locations

1

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

2

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

C

Charite Ricker, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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