Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422455
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-15
Brief Title:
Access to Genetic Testing in Underserved Patients With Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 racialethnic 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02187 | REGISTRY | None | None |
| 19PS-22-3 | OTHER | None | None |
| P30CA014089 | NIH | None | None |
| R01CA263532 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchR01CA263532 |