NCT05111639

Brief Summary

This proposal will aim to improve the understanding about the treatment decision in the type of urinary diversion and identify patient knowledge gaps about uncertainty around patient decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

October 19, 2021

Last Update Submit

August 11, 2025

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the decision aid tool

    Matlock DD, Keech TA, McKenzie MB, Bronsert MR, Nowels CT, Kutner JS. Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

    12 months

Secondary Outcomes (4)

  • Knowledge

    12 months

  • Decisional Quality

    12 months

  • Decisional Regret

    12 months

  • Value Concordance

    12 months

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants (patients and urologists) will be recruited for qualitative interviews as follows: 1) 10 bladder cancer patients who have undergone urinary diversion within the last year; 2) 10 bladder cancer patients who are undergoing urinary diversion in the next 3 months; and 3) 10 individual interviews will be done with urologists currently performing cystectomy and urinary diversions.

You may qualify if:

  • Any patient undergoing or who has undergone urinary diversion for bladder cancer
  • \<90 years old

You may not qualify if:

  • Any patient undergoing or undergone urinary diversion for other reason than bladder cancer
  • aged \>90 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Janet Kukreja

    Colorado Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 8, 2021

Study Start

August 24, 2021

Primary Completion

February 21, 2025

Study Completion

February 21, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations

US(1)