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

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

INTRODUCTION

  • Org Study ID: IRB23-0773
  • Secondary ID: N/A
  • NCT ID: NCT06427824
  • Sponsor: University of Chicago

DESCRIPTION

Short Summary: This study helps people with bladder cancer who need surgery by teaching them ways to lower surgery problems. They watch videos and fill out forms. The study is ongoing, and the results are not ready. The aim is to see if videos and extra help make surgery easier. 
  • Background/Introduction: This study helps people with bladder cancer who plan to have surgery. The surgery is called a cystectomy. The study aims to teach them how to lessen problems after surgery.
  • Methods: Participants will watch helpful videos. They will also fill out forms about what they learn. People are split into two groups by chance. One group gets videos and extra help after surgery.
  • Findings/Results: The study is still looking for people to join. Results are not ready yet.
  • Conclusion: The goal is to help people with bladder cancer have fewer problems from surgery. Results will tell if the videos and extra help are useful.

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    August 9, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants Referred to Educational Program

Primary Outcome 1 - Timeframe: 90 days

CONDITION

  • Bladder Cancer

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)

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Piyush Agarwal

Role: Principal Investigator

Affiliation: University of Chicago

Overall Contact

Name: Piyush K Agarwal, MD

Phone: 773-702-3080

Email: [email protected]

LOCATION

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