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NCT Number: NCT06427824

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

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60615, United States

Location status: Recruiting

Location contact

Piyush Agarwal, MD

CONTACT

773-702-3080

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

Other

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.

Geriatric Service/ Discharge Planning

Other

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.

questionnaires

Other

These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Piyush K Agarwal, MD

CONTACT

[email protected]

773-702-3080

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 24, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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