Pharmacogenomic Testing to Personalize Supportive Oncology

Wake Forest University Health Sciences70 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Depression Pain

Interventions

Preemptive Pharmacogenomic TestingOTHER

The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months

Data from ClinicalTrials.gov

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