Pharmacogenomic Testing to Personalize Supportive Oncology

Evaluating the Use of Preemptive Pharmacogenomic Testing to Personalize Supportive Oncology

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Cancer
• Intervention / Treatment: Other: Preemptive Pharmacogenomic Testing

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Written informed consent and HIPAA authorization for release of personal health information.
• Completion of ESAS at initial palliative medicine clinic visit, presenting with moderate to high pain (≥ 4/10) and/or depression (≥ 3/10).
• New patients ≥ 18 years of age who have had an initial visit in the Department of Supportive Oncology's palliative medicine clinic with hematologic malignancy or any stage solid tumor malignancy according to the provider.
• Agree to at least one additional palliative medicine clinic visit per protocol.
• Able to provide a buccal sample for PGx testing.

Exclusion Criteria

• Psychiatric illness, social situations, or active/recent (within 30 days) history of illicit substance (e.g. cocaine, heroin) abuse that would limit compliance with study requirements (e.g. clinic visits, medication compliance, etc.) as determined by the Investigator.
• Patients who have had prior multiple visits in palliative medicine clinic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacogenomic Testing; A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.	Other: Preemptive Pharmacogenomic Testing; The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization of PGx results	Estimate the proportions of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results within any of the study visits after the Baseline study visit.	21, 42, 63 and 84 days after the baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Impact	Determine the impact of PGx on treatment outcomes by measuring pain scores on a scale of 0-10 (0 no pain, 10 worst possible severity) using the Edmonton Symptom Assessment Scale (ESAS) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.	21, 42, 63 and 84 days after the baseline visit
Depression Scores Impact	Determine the impact of PGx on treatment outcomes by measuring depression on a scale of 0-27 (0 no depression, 27 severe depression) using the Patient Health Questionnaire 9 (PHQ9) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.	21, 42, 63 and 84 days after the baseline visit
Compare Health Care Utilization	Compare health care utilization (HCRU) using cost in USD, including but not limited to cost associated with inpatient, emergency department, outpatient, and pharmacy encounters between subjects receiving PGx testing and matched controls receiving clinical management alone.	84 days
Subject Perspectives	Describe subject perspectives of PGx testing using a survey administered to subjects after/at the Final visit (or sooner if withdrawn).	Assessed at the final study visit (day 84)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Actionable Genotypes	Determine the frequencies of actionable genotypes that result in drug/dose selection or modification(s) during the study period.	84 days
Types of New Medications Prescribed	Describe the types of new medications prescribed or medication/dose adjustments based on the PGx results.	84 days
Frequency of Drug/Gene Interactions	Determine the frequency of drug/gene interactions present at the Baseline and the Final study visit using CPIC guidelines and FDA's pharmacogenomics table.	Baseline (day 0) and day 84

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jai Patel, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IRB00081754; Pro00045081; LCI-SUPP-NOS-PGX-001 (Other Identifier: Atrium Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No