Access to Genetic Testing in Underserved Patients With Cancer
NCT ID: NCT06422455
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2023-10-24
2028-10-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention Phase Arm A (PERLA)
Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
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
Intervention Phase Arm B (usual care)
Patients receive access to usual care pre- and post-test provider-based genetic counseling.
Best Practice
Receive provider-based genetic counseling
Electronic Health Record Review
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with none of the listed cancer diagnoses and clinical characteristics
* Healthcare provider who do not treats cancer patients
Exclusion Criteria
* Patients who cannot see, read, or write
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Northeastern University
OTHER
Dana-Farber Cancer Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Charite Ricker, MS
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-02187
Identifier Type: REGISTRY
Identifier Source: secondary_id
19PS-24-3
Identifier Type: OTHER
Identifier Source: secondary_id
19PS-24-3
Identifier Type: -
Identifier Source: org_study_id
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