Access to Genetic Testing in Underserved Patients With Cancer

University of Southern California

Status

Enrolling

Conditions

Stage IVB Prostate Cancer American Joint Committee on Cancer v8

Male Breast Carcinoma

Triple-Negative Breast Carcinoma

Ovarian Carcinoma

Metastatic Prostate Carcinoma

Malignant Solid Neoplasm

Breast Carcinoma

Pancreatic Exocrine Neoplasm

Treatments

Other: Genetic Counseling

Other: Educational Intervention

Other: Survey Administration

Other: Electronic Health Record Review

Other: Best Practice

Other: Interview

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06422455

19PS-24-3 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2024-02187 (Registry Identifier)

R01CA263532 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To obtain patient and provider input on the optimal content and format of a new relational agent (RA) intervention ("PERLA") for automated pre-test genetics education.

II. To obtain patient feedback on the usability of the English- and Spanish-language PERLAs.

III. To determine the acceptability of the newly designed English- and Spanish-language PERLAs among patients with cancer.

IV. To evaluate the impact of the English- and Spanish-language PERLAs on the proportion of patients who meet cancer-based genetic testing guidelines who receive genetic test results within 3 months of initiating cancer care.

V. To evaluate the potential barriers and facilitators to implementation of PERLA in the clinical setting.

OUTLINE:

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

USABILITY PHASE: Participants attend usability testing and provide feedback through cognitive interviews.

PILOT TESTING PHASE: Participants evaluate the newly developed PERLAs and provide feedback through focused interviews and structured assessment.

INTERVENTION PHASE: Patients are randomized to 1 of 2 arms.

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

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

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

After completion of study intervention, patients are followed up at 1, 3, and 6 months.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

800 participants in 2 patient groups

Intervention Phase Arm A (PERLA)

Experimental group

Description:

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

Treatment: