Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy

September 29, 2025 updated by: University of Chicago

Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial

This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on providing an educational program for participants/people with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. The goal of this study is to educate people with bladder cancer and ask them to also fill out questionnaires about the education program and if they used any of the strategies that learn during the study.

Participants in this study will be divided into two different study groups (one group that watches educational videos before surgery and one group that watches educational videos before surgery and also receives geriatric services and follow up visits after surgery). Each participant will be randomized (randomly assigned) to one of two study groups. That means that there is a 50/50 chance (like flipping a coin) that each participant will end up in either group.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60615
        • Recruiting
        • University of Chicago Medicine Comprehensive Cancer Center
        • Contact:
          • Piyush Agarwal, MD
          • Phone Number: 773-702-3080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants capable of giving consent
  • Participants undergoing radical cystectomy (both for curative and palliative intent) for bladder cancer diagnosed by tissue pathology with urinary diversion at the University of Chicago
  • Participants undergoing neoadjuvant chemotherapy will be included
  • Participants will be included regardless of gender, race or ethnicity
  • Participants greater than or equal to 65 years of age

Exclusion Criteria

  • Radical cystectomy for non-oncologic indications
  • Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants Who Watch Educational Videos Before Surgery
Participants in this group will attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before and after surgery.
Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.
Other: Questionnaires
These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.
Experimental: Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

Participants in this group will also attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before surgery.

In addition to attending the educational program (via video) and receiving informational handouts, participants in this group will also meet with the study doctor and/or members of the study team after surgery to help plan their hospital discharge and reinforce/use the strategies they learned in the educational session after surgery.
Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.
Other: Questionnaires
These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.
Other: Geriatric Service/ Discharge Planning
A geriatric team will meet with participants after surgery to help them reinforce the strategies they learned in the education video sessions. As part of a geriatric service, this team will also help participants plan/coordinate their discharge from the hospital after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Referred to Educational Program
Time Frame: 90 days
Assess the feasibility of an educational program designed for participants undergoing radical cystectomy by measuring the number of participants referred to the study team/program.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey responses from participants who completed some or all of educational program
Time Frame: 90 days
Assess the acceptability of an educational program designed for participants undergoing radical cystectomy by measuring/surveying the number of study participants who completed at least some of the intervention.
90 days
Number of self-reported interventions/strategies used among participants after watching educational videos
Time Frame: 90 days
Assess the adoptability of an educational program designed for participants undergoing radical cystectomy by measuring the number of self-reported interventions that participants reported after the educational program
90 days
30-day Hospital Readmission Rates Among All Participants
Time Frame: 30 days
Assess impact of educational program by comparing the differences between hospital readmission rate at 30 days between both study cohorts.
30 days
90-day Hospital Readmission Rates Among All Participants
Time Frame: 90 days
Assess impact of educational program by comparing the differences between hospital readmission rate at 90 days between both study cohorts.
90 days
Complication Rates Reported Among Participants
Time Frame: 90 days
Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Piyush Agarwal, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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