Access to Genetic Testing in Underserved Patients With Cancer

Not Applicable

Recruiting

• Conditions: Pancreatic Exocrine Neoplasm; Triple-Negative Breast Carcinoma; Breast Carcinoma; Stage IVB Prostate Cancer American Joint Committee on Cancer v8; Male Breast Carcinoma; Malignant Solid Neoplasm; Metastatic Prostate Carcinoma; Ovarian Carcinoma
• Interventions: Other: Educational Intervention; Other: Best Practice; Other: Electronic Health Record Review; Other: Genetic Counseling; Other: Survey Administration; Other: Interview

• Registration Number: NCT06422455
• Lead Sponsor: University of Southern California

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.

Detailed 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.

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2027-10-24
• Study Completion: 2028-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Phase Arm A (PERLA)	Genetic Counseling	Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
Intervention Phase Arm B (usual care)	Survey Administration	Patients receive access to usual care pre- and post-test provider-based genetic counseling.
Intervention Phase Arm A (PERLA)	Educational Intervention	Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
Intervention Phase Arm A (PERLA)	Electronic Health Record Review	Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
Intervention Phase Arm A (PERLA)	Interview	Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
Intervention Phase Arm A (PERLA)	Survey Administration	Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
Intervention Phase Arm B (usual care)	Best Practice	Patients receive access to usual care pre- and post-test provider-based genetic counseling.
Intervention Phase Arm B (usual care)	Electronic Health Record Review	Patients receive access to usual care pre- and post-test provider-based genetic counseling.

Primary Outcome Measures

Name	Time	Method
Proportion of participants who receive genetic testing	Up to 3 months	The proportion of participants who receive genetic testing will be reported.

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcomes	Up to 3 months	Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined.

Trial Locations

Locations (2)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

University of Rochester; 🇺🇸 Rochester, New York, United States