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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427824
• Other study ID #: IRB23-0773
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Piyush K Agarwal, MD
• Phone: 773-702-3080
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Referred to Educational Program	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	Survey responses from participants who completed some or all of educational program	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
Secondary	Number of self-reported interventions/strategies used among participants after watching educational videos	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
Secondary	30-day Hospital Readmission Rates Among All Participants	Assess impact of educational program by comparing the differences between hospital readmission rate at 30 days between both study cohorts.	30 days
Secondary	90-day Hospital Readmission Rates Among All Participants	Assess impact of educational program by comparing the differences between hospital readmission rate at 90 days between both study cohorts.	90 days
Secondary	Complication Rates Reported Among Participants	Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups.	90 days