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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Procedure: Biospecimen Collection. Undergo collection of saliva

Intervention public domain (ClinicalTrials.gov)

Other: Genetic Testing. Undergo pharmacogenomics testing

Intervention public domain (ClinicalTrials.gov)

Other: Quality-of-Life Assessment. Ancillary studies

Intervention public domain (ClinicalTrials.gov)

Other: Questionnaire Administration. Ancillary studies

Arm public domain (ClinicalTrials.gov)

Screening (pharmacogenomics testing) (experimental): 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.

Primary outcome public domain (ClinicalTrials.gov)

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 outcome public domain (ClinicalTrials.gov)

Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients. Time frame: Up to 3 months.

Eligibility public domain (ClinicalTrials.gov)

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)

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 197 participants (actual).