Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500301
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2020-07-27
Brief Title:
Pharmacogenomic Testing to Personalize Supportive Oncology
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Evaluating the Use of Preemptive Pharmacogenomic Testing to Personalize Supportive Oncology
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The purpose of this study is to evaluate pharmacogenomics PGx guided drug prescribing for pain and depression in patients with cancer The investigators aim to understand how PGx testing can be used to improve medication management for pain and depression and whether PGx-guided prescribing improves these symptoms and quality of life compared to historical controls
Detailed Description:
This is a prospective clinical trial of adult cancer patients presenting with pain and depression newly referred to the Department of Supportive Oncology and receiving preemptive PGx testing for genes related to supportive care prior to the first clinic visit Genotyping results will be returned within approximately 4-5 business days A PGx specialist will provide detailed clinical interpretations to the referring provider and upload a copy of the test results into the subjects medical chart A consultation note will also be placed in each subjects chart detailing the PGx results Supportive Oncology clinicians will be instructed to consult a pharmacist to evaluate PGx test results prior to prescribing supportive care therapies especially pain and depression medications The number of consults and recommendations will be documented in addition to test results demographic data medicalmedication history ESAS symptom scores PHQ9 depression scores and side effects of supportive therapy The number of ambulatory clinic visits and hospitalizations will be used to estimate health care utilization and costs Subjects will complete a short survey at the end of the study period regarding their knowledge about PGx and whether access to PGx information improves satisfaction with care and communication
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LCI-SUPP-NOS-PGX-001 | OTHER | Atrium Health | None |
| Pro00045081 | None | None | None |