NCT04500301

Pharmacogenomic Testing to Personalize Supportive Oncology

Evaluating the Use of Preemptive Pharmacogenomic Testing to Personalize Supportive Oncology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 subject's medical chart. A consultation note will also be placed in each subject's 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, medical/medication 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.

Conditions

• Cancer
• Depression
• Pain

Interventions

Type	Name	Description
OTHER	Preemptive Pharmacogenomic Testing	The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.

Timeline

• Start date: 2020-12-02
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2020-08-05
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

1 site across 1 country: United States