Recruiting

Genetic Testing

Sponsor:

University of Southern California

Code:

NCT06422455

Conditions

Breast Carcinoma

Male Breast Carcinoma

Malignant Solid Neoplasm

Metastatic Prostate Carcinoma

Ovarian Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Educational Intervention

Electronic Health Record Review

Genetic Counseling

Interview

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Male Breast Carcinoma

Malignant Solid Neoplasm

Metastatic Prostate Carcinoma

Ovarian Carcinoma

Study ID

NCT06422455

Start date

Oct 24, 2023

Status verified date

Mar, 2026

Completion date

Oct 24, 2028

Anticipated

Primary completion date

Oct 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age > 18 years old
  • Diagnosed with 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
  • Male breast cancer OR
  • 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

Exclusion Criteria:

  • Patients who cannot provide informed consent
  • Patients who cannot see, read, or write
  • Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish
  • Patients with none of the listed cancer diagnoses and clinical characteristics
  • Healthcare provider who do not treats cancer patients

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Phase Arm A (PERLA)

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

active comparator: Intervention Phase Arm B (usual care)

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

Interventions

Best Practice

Receive provider-based genetic counseling

Educational Intervention

Receive genetics education

Electronic Health Record Review

Ancillary studies

Genetic Counseling

Receive provider-based genetic counseling

Interview

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Proportion of participants who receive genetic testing [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Charite Ricker, MS

323-409-7710ricker@usc.edu

Locations

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Charite Ricker

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Meghan L. Underhill

More Information

Sponsor

University of Southern California

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-03-18.