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

NCT06427824 | Recruiting DMC

• 1 other identifier: IRB23-0773
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

cystectomy; radical cystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Survey responses from participants who completed some or all of educational program

  90 days

• Number of self-reported interventions/strategies used among participants after watching educational videos

  90 days

• 30-day Hospital Readmission Rates Among All Participants

  30 days

• 90-day Hospital Readmission Rates Among All Participants

  90 days

• Complication Rates Reported Among Participants

  90 days

Study Arms (2)

Participants Who Watch Educational Videos Before Surgery

EXPERIMENTAL

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); Other: Questionnaires

Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

EXPERIMENTAL

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); Other: Geriatric Service/ Discharge Planning; Other: Questionnaires

Interventions

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.

Participants Who Watch Educational Videos Before Surgery; Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

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.

Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

Questionnaires OTHER

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

Participants Who Watch Educational Videos Before Surgery; Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60615, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Surgical Procedures, Operative; Patient Discharge; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Hospitalization; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Piyush Agarwal

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piyush K Agarwal, MD

CONTACT

773-702-3080; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)