Pharmacogenomic Testing to Personalize Supportive Oncology

Not Applicable

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Pharmacogenomic Testing	Preemptive Pharmacogenomic Testing	A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.

Primary Outcome Measures

Name	Time	Method
Utilization of PGx results	16 +/- 4 weeks after the baseline visit	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.

Secondary Outcome Measures

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subject perspectives of PGx testing using a survey administered to subjects after/at the Final visit (or sooner if withdrawn).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

Locations (1): Levine Cancer Institute
🇺🇸
Charlotte, North Carolina, United States

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