Clinical trial NCT06427824: Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy
Official title: Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: cystectomy
radical cystectomy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants Referred to Educational Program
timeFrame: 90 days
Secondary outcomes:
measure: Survey responses from participants who completed some or all of educational program
timeFrame: 90 days
measure: Number of self-reported interventions/strategies used among participants after watching educational videos
timeFrame: 90 days
measure: 30-day Hospital Readmission Rates Among All Participants
timeFrame: 30 days
measure: 90-day Hospital Readmission Rates Among All Participants
timeFrame: 90 days
measure: Complication Rates Reported Among Participants
timeFrame: 90 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Piyush Agarwal
role: PRINCIPAL_INVESTIGATOR
References: