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Trial Title:
Access to Genetic Testing in Underserved Patients With Cancer
NCT ID:
NCT06422455
Condition:
Breast Carcinoma
Male Breast Carcinoma
Malignant Solid Neoplasm
Metastatic Prostate Carcinoma
Ovarian Carcinoma
Pancreatic Exocrine Neoplasm
Stage IVB Prostate Cancer American Joint Committee on Cancer v8
Triple-Negative Breast Carcinoma
Conditions: Official terms:
Carcinoma
Neoplasms
Breast Neoplasms
Breast Neoplasms, Male
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive provider-based genetic counseling
Arm group label:
Intervention Phase Arm B (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive genetics education
Arm group label:
Intervention Phase Arm A (PERLA)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Intervention Phase Arm A (PERLA)
Arm group label:
Intervention Phase Arm B (usual care)
Intervention type:
Other
Intervention name:
Genetic Counseling
Description:
Receive provider-based genetic counseling
Arm group label:
Intervention Phase Arm A (PERLA)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Intervention Phase Arm A (PERLA)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Intervention Phase Arm A (PERLA)
Arm group label:
Intervention Phase Arm B (usual care)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Contact:
Last name:
Charite Ricker
Phone:
323-409-7710
Email:
ricker@usc.edu
Investigator:
Last name:
Charite Ricker
Email:
Principal Investigator
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Contact:
Last name:
Meghan L. Underhill
Email:
meghan_blazey@urmc.rochester.edu
Investigator:
Last name:
Meghan L. Underhill
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06422455
