Discharge Medication Use Post-Operatively in GU Cancer Patients
ConditionGenitourinary Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
The main purpose of this research study is to determine the amount of opioids that are taken after discharge following a cystectomy, nephrectomy (partial or total), or prostatectomy surgeries via a 30-day post- discharge opioid use and disposal survey. We will also evaluate the impact of an opioid disposal education pamphlet on proper disposal of unused opioids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent and HIPAA authorization for release of personal health information.
Age ≥ 18 years at the time of enrollment
Scheduled to undergo surgical cystectomy, partial or total nephrectomy or prostatectomy for a cancer diagnosis.
Ability to read and understand the English and/or Spanish language.
Disqualifiers
None
Trial population
Participants ≥ 18 years of age or older who will undergo planned cystectomy, nephrectomy (partial or total), or prostatectomy for a GU cancer diagnosis will be approached to enroll into the study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Opioid Medication Disposal Education
Other interventionEducation on opioid medication disposal will be provided in the form of a pamphlet created by Atrium Health based on FDA resources and will be given to all participants at the time of consent (cystectomy, nephrectomy, prostatectomy) beginning in the second year, approximately 13 months from when the first participant is enrolled or until a minimum of 100 evaluable participants are enrolled in the pre-education cohort, whichever occurs last.
Treatment groups
684 Participants
are divided into 2 treatment groupsGroup A: Pre-Education Cohort0 interventions
Group B: Post-Education Cohort1 intervention
Trial outcomes
Primary outcomes
1
Discharge opioids consumed in 30 days after discharge
For each participant who was prescribed an opioid medication after urology surgery, the number of opioid pills consumed in 30 days after discharge will be captured as a categorical variable from the "Opioid Use and Disposal Survey". Participant-reported options include None, About one-fourth of all pills, About half of all pills, About three-fourths of all pills, or All. Participants who report that they received an opioid prescription but did not fill it will be captured as taking None.
Time frame
30 days after dischargeSecondary outcomes
1
Number of participants filling opioid prescription
For each participant who was prescribed an opioid medication after urology surgery, whether or not the prescription was filled will be reported as a binary variable on the "Opioid Use and Disposal Survey".
Time frame
30 days after discharge2
Participant-reported reasons for not filling opioid prescription
For each participant who reported not filling their opioid prescription, reason for not filling the prescription will be captured on the "Opioid Use and Disposal Survey". Options include: Pain was controlled without taking any opioid medications, Concern about side effects, Concern about developing addiction or dependence, Other (explain).
Time frame
30 days after discharge3
Participant-reported reasons for not taking all pills
For each participant who reported filling their opioid prescription but did not take all of their pills, reason for not taking all of the prescribed pills will be captured on the "Opioid Use and Disposal Survey". Options include: Pain was controlled without taking all pills, Side effects were too severe, Concern about developing addiction or dependence, Other (explain).
Time frame
30 days after discharge4
Participant-reported pain control after discharge
Each participant will report what their average daily pain score was in the first week after discharge on the "Opioid Use and Disposal Survey". This will be reported on a scale of 0 - 10, with 0 indicating "no pain" and 10 indicating "worst possible pain".
Time frame
30 days after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Source ClinicalTrials.gov