Access to Genetic Testing in Underserved Patients With Cancer

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.

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