NCT06795087

Brief 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. We will also evaluate the impact of an opioid disposal education pamphlet on proper disposal of unused opioids.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Feb 2025Jul 2027

First Submitted

Initial submission to the registry

January 24, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

February 21, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

January 24, 2025

Last Update Submit

January 20, 2026

Conditions

Genitourinary Cancer

Keywords

Genitourinary CancerCystectomiesNephrectomiesProstatectomies

Outcome Measures

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.

    30 days after discharge

Secondary Outcomes (16)

  • Number of participants filling opioid prescription

    30 days after discharge

  • Participant-reported reasons for not filling opioid prescription

    30 days after discharge

  • Participant-reported reasons for not taking all pills

    30 days after discharge

  • Participant-reported pain control after discharge

    30 days after discharge

  • Number of participants receiving a refill after discharge

    30 days after discharge

  • +11 more secondary outcomes

Study Arms (2)

Pre-Education Cohort

Post-Education Cohort

Other: Opioid Medication Disposal Education

Interventions

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 discharge (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.

Post-Education Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Stephen Riggs, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita Dzhanumova

CONTACT

704-355-2000Margarita.Dzhanumova@advocatehealth.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 27, 2025

Study Start

February 21, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

US(1)