Access to Genetic Testing in Underserved Patients With Cancer

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422455
• Other study ID #: 19PS-22-3
• Secondary ID: NCI-2024-0218719
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Charite Ricker, MS
• Phone: 323-409-7710
• Email: ricker[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Breast Neoplasms, Male
• Carcinoma
• Male Breast Carcinoma
• Malignant Solid Neoplasm
• Metastatic Prostate Carcinoma
• Neoplasms
• Ovarian Carcinoma
• Triple-Negative Breast Carcinoma

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who receive genetic testing	The proportion of participants who receive genetic testing will be reported.	Up 3 months
Secondary	Patient-reported outcomes	Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined.	Up to 3 months