This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
800
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGPain control.
Measuring changes in composite pain intensity rating via the numeric rating scale: * Brief Pain Inventory-Short Form (BPI-SF) * Score range: 0 (no pain) to 10 (most pain) * Composite pain intensity score (mean of worst, least, average, and current pain) From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.
Time frame: 45 days
Pain Medication Regimen Changes
Pain medication regimen changes will be assessed for patients who were taking an opioid metabolized primarily by CYP2D6. Pain medication regimen changes from baseline to day 45. The timing of subsequent changes in pain regimes after initial opioid selection will also be recorded.
Time frame: 45 days
Hospitalization or Emergency Visit for Pain Control
The rates of hospitalization and emergency room visits for pain are examined with the rates of increased utilization of health care resources, such as emergency department visits, hospitalizations, and pain consultations. Rates of hospitalization or emergency room visits from baseline to day 45.
Time frame: 45 days
Cumulative Morphine Equivalents Required
Cumulative Morphine Equivalents will be defined as total amount of opioids taken by a patient that is converted into its morphine equivalent. Dose and frequency of each opioid given during 45 days after its index prescription will be considered during calculation to give final values, which will be compared to Cumulative Morphine Equivalents for Control arms treated per standard of care.
Time frame: 45 days
Type of First Opioid Prescribed
Time frame: From enrollment until study end (up to 5 years)
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