Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer

Early Phase 1CompletedNCT04067960

Mayo Clinic197 enrolled

Overview

This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.

PRIMARY OBJECTIVES: I. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing. II. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers. OUTLINE: Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing. After completion of study, patients are followed for up to 1 year.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

197

Conditions

Anatomic Stage III Breast Cancer AJCC v8

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient enrolled to Mayo Clinic IRB: 18-000326 * Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer * Individuals have agreed to participate and signed the study informed consent form Exclusion Criteria: * Patients with cancer types other than the ones mentioned above * Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent * Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)

Outcomes

Primary Outcomes

Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing

Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.

Time frame: Baseline up to 3 months post consent

Secondary Outcomes

Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients

Will qualitatively assess provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients via the provider survey. Provider survey responses will be examined to determine the range of perceptions and experiences associated with PGx testing and result reporting for patient tests. Descriptive statistics will be used to report provider survey results.

Time frame: Up to 3 months