Clinical trial NCT04500301: Pharmacogenomic Testing to Personalize Supportive Oncology
Official title: Evaluating the Use of Preemptive Pharmacogenomic Testing to Personalize Supportive Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Depression
Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Receiving at Least One Drug/Dose Selection or Modification Based on PGx Results
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jai Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References: