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
Proportion of Participants Receiving at Least One Drug/Dose Selection or Modification Based on PGx Results	Estimate the proportion of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results at any study visit where PGx results are available. A binary variable was determined for each subject indicating whether or not they received at least one drug/dose selection or modification based on PGx results where PGx results were available. The proportion of participants receiving at least one drug/dose selection or modification based on PGx results at any study visit where PGx results were available was calculated among all subjects in the analysis population.	From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months

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.	+/- 1 week, 8 +/- 2 weeks, 12 +/- 3 weeks, and 16 +/- 4 weeks 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.	4 +/- 1 week, 8 +/- 2 weeks, 12 +/- 3 weeks, and 16 +/- 4 weeks after the baseline visit
Subject Perspectives	Describe subject perspectives of PGx testing using a survey administered to subjects after/at the Final visit (or sooner if withdrawn).	Week 16 +/- 4

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.	Week 16 +/- 4
Types of New Medications Prescribed	Describe the types of new medications prescribed or medication/dose adjustments based on the PGx results.	Week 16 +/- 4
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 Week 16 +/- 4
Best practice advisory (BPA) alerts for all prescriptions	Determine the proportion of participants enrolled after the transition to Epic who had a BPA fire in the EMR.	Assessed at the final study visit (Week 16 +/- 4)
Best practice advisory alerts for all new prescriptions	Determine the number of BPAs per participant enrolled after the transition to Epic.	Assessed at the final study visit (Week 16 +/-4 weeks)
Best practice advisory alerts for all alerts	Summarize and describe the types and actions taken from BPAs in participants enrolled after the transition to Epic.	Assessed at the final study visit (Week 16 +/- 4 weeks)

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

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