Genitourinary CancerNCT06795087
Discharge Medication Use Post-Operatively in GU Cancer Patients
An observational study of Genitourinary Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genitourinary Cancer
- What is being tested?
- Opioid Medication Disposal Education
- How many people
- 684 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Margarita Dzhanumova, 704-355-2000, Margarita.Dzhanumova@advocatehealth.org
Stephen Riggs, MD
About this study
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.
Read the detailed description
This prospective, non-therapeutic trial aims to evaluate the amount of prescribed opioid medications GU cancer patients are consuming post-discharge following surgical procedure of cystectomies, nephrectomies, and prostatectomies.
Enrolled participants will complete a 30-day post-discharge survey evaluating the usage of prescribed opioids and opioid disposal habits, as well as a patient satisfaction survey. Furthermore, participants will be offered to complete an optional CAHPS® Surgical Care Survey to assess patients' experiences with surgical care during in hospital stay and outpatient office visits.
Education on opioid medication disposal will be provided in the form of a pamphlet to participants that are enrolled beginning in year 2 (approximately month 13) from when the first participant is enrolled or after a minimum of 100 evaluable participants are enrolled in the pre-education cohort.
- Conditions
- Genitourinary Cancer
- Being tested
- Opioid Medication Disposal Education
- Keywords
- Genitourinary Cancer, Cystectomies, Nephrectomies, Prostatectomies
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Medication Disposal EducationOther
Education 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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Education Cohort | Not described | |
| Post-Education Cohort | Not described Receives: Other: Opioid Medication Disposal Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after discharge
Secondary outcomes (16)
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".
Measured: 30 days after discharge
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).
Measured: 30 days after discharge
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).
Measured: 30 days after discharge
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".
Measured: 30 days after discharge
Number of participants receiving a refill after discharge
For each participant who was prescribed an opioid medication after urology surgery, whether or not the participant received a refill of opioid medication(s) during the 30-day period post-discharge will be captured as a binary variable from the electronic medical records.
Measured: 30 days after discharge
Participant-reported disposal method for left-over opioids
For each participant who filled the opioid prescription that they received, the method of disposal or storage of excess opioid medication will be captured as a categorical variable on the "Opioid Use and Disposal Survey". The possible methods include: Threw away in trash, Stored in an unlocked cabinet, Stored in a locked cabinet, Flushed down the toilet, Brought to a pharmacy or hospital, Brought to a law enforcement center, Still taking prescribed opioids, Other (explain)
Measured: 30 days after discharge
Patient Satisfaction Survey Item 1 - "I would recommend this institution to a friend or family for treatment."
The satisfaction level with surgery will be captured for each participant from a single administration of a study-specific "Patient Satisfaction Survey" that contains 5 items and is administered 30 days after discharge. This item will be measured for each participant with 5-point Likert scale response options (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree).
Measured: 30 days after discharge
Patient Satisfaction Survey Item 2 - "The staff provided adequate information and education prior to discharge regarding my recovery at home (ex. wound care and pain management)."
The satisfaction level with surgery will be captured for each participant from a single administration of a study-specific "Patient Satisfaction Survey" administered 30 days after discharge. This item will be measured for each participant with 5-point Likert scale response options (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree).
Measured: 30 days after discharge
Patient Satisfaction Survey Item 3 - "Prior to my discharge, I or my caregiver clearly understood the timing and purpose for taking each of my medications."
The satisfaction level with surgery will be captured for each participant from a single administration of a study-specific "Patient Satisfaction Survey" administered 30 days after discharge. This item will be measured for each participant with 5-point Likert scale response options (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree).
Measured: 30 days after discharge
Patient Satisfaction Survey Item 4 - "During the hospital stay, nurses and doctors treated me with courtesy and respect."
The satisfaction level with surgery will be captured for each participant from a single administration of a study-specific "Patient Satisfaction Survey" administered 30 days after discharge. This item will be measured for each participant with 5-point Likert scale response options (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree).
Measured: 30 days after discharge
Patient Satisfaction Survey Item 5 - "Following prostatectomy, I preferred to be discharged the same day."
The satisfaction level with surgery will be captured for each participant from a single administration of a study-specific "Patient Satisfaction Survey" administered 30 days after discharge. This item will be measured for each participant with a 7-level categorical response (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree, I did not have prostatectomy, I had a prostatectomy however, I was not discharged the same day).
Measured: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of preparation for surgery
From the CAHPS Surgical Care Survey, a binary variable will indicate whether or not the participants reported a top-box response for questions in the "preparation for surgery" domain. Response options include: Yes, definitely (top-box); Yes somewhat; No
Measured: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of preoperative communication
From the CAHPS Surgical Care Survey, a binary variable will indicate whether or not the participants reported a top-box response for questions in the "preoperative communication" domain. Response options include: Yes, definitely (top-box); Yes somewhat; No
Measured: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of day of surgery attentiveness
From the CAHPS Surgical Care Survey, a binary variable will indicate whether or not the participants reported a top-box response for questions in the "day of surgery attentiveness" domain. Response options include: Yes (top-box); No
Measured: 30 days after discharge
CAHPS Surgical Care Survey - Patients' rating of surgeon
From the CAHPS Surgical Care Survey, patient-reported rating of their surgeon on a scale of 0 to 10, with 0 being the worst and 10 being the best.
Measured: 30 days after discharge
CAHPS Surgical Care Survey - Patients' rating of anesthesiologist
From the CAHPS Surgical Care Survey, patient reported rating of their anesthesiologist on a scale of 0 to 10, with 0 being the worst and 10 being the best.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start21 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Stephen Riggs, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795087
- Sponsor's protocol ID
- IRB00121391
- Other IDs
- LCI-GU-PO-NMC-001
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Medication Use Post-Operatively in GU Cancer Patients
- ClinicalTrials.gov ID
- NCT06795087
- Acronym / sponsor ID
- IRB00121391
- Conditions
- Genitourinary Cancer
- Keywords
- Genitourinary Cancer, Cystectomies, Nephrectomies, Prostatectomies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, non-therapeutic trial aims to evaluate the amount of prescribed opioid medications GU cancer patients are consuming post-discharge following surgical procedure of cystectomies, nephrectomies, and prostatectomies.
Enrolled participants will complete a 30-day post-discharge survey evaluating the usage of prescribed opioids and opioid disposal habits, as well as a patient satisfaction survey. Furthermore, participants will be offered to complete an optional CAHPS® Surgical Care Survey to assess patients' experiences with surgical care during in hospital stay and outpatient office visits.
Education on opioid medication disposal will be provided in the form of a pamphlet to participants that are enrolled beginning in year 2 (approximately month 13) from when the first participant is enrolled or after a minimum of 100 evaluable participants are enrolled in the pre-education cohort.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Education Cohort | – | – |
| Post-Education Cohort | – | Other: Opioid Medication Disposal Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Medication Disposal EducationEducation 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. | Other | Post-Education Cohort |
Primary outcome
Discharge opioids consumed in 30 days after discharge
Time frame: 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.
16 secondary outcomes
Number of participants filling opioid prescription
Time frame: 30 days after discharge
Participant-reported reasons for not filling opioid prescription
Time frame: 30 days after discharge
Participant-reported reasons for not taking all pills
Time frame: 30 days after discharge
Participant-reported pain control after discharge
Time frame: 30 days after discharge
Number of participants receiving a refill after discharge
Time frame: 30 days after discharge
Participant-reported disposal method for left-over opioids
Time frame: 30 days after discharge
Patient Satisfaction Survey Item 1 - "I would recommend this institution to a friend or family for treatment."
Time frame: 30 days after discharge
Patient Satisfaction Survey Item 2 - "The staff provided adequate information and education prior to discharge regarding my recovery at home (ex. wound care and pain management)."
Time frame: 30 days after discharge
Patient Satisfaction Survey Item 3 - "Prior to my discharge, I or my caregiver clearly understood the timing and purpose for taking each of my medications."
Time frame: 30 days after discharge
Patient Satisfaction Survey Item 4 - "During the hospital stay, nurses and doctors treated me with courtesy and respect."
Time frame: 30 days after discharge
Patient Satisfaction Survey Item 5 - "Following prostatectomy, I preferred to be discharged the same day."
Time frame: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of preparation for surgery
Time frame: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of preoperative communication
Time frame: 30 days after discharge
CAHPS Surgical Care Survey - Number of patients with top-box ratings of day of surgery attentiveness
Time frame: 30 days after discharge
CAHPS Surgical Care Survey - Patients' rating of surgeon
Time frame: 30 days after discharge
CAHPS Surgical Care Survey - Patients' rating of anesthesiologist
Time frame: 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Related trials for Genitourinary Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Riggs, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margarita Dzhanumova (704-355-2000, Margarita.Dzhanumova@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge opioids consumed in 30 days after discharge (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.