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Trial Title:
Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy
NCT ID:
NCT06427824
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
cystectomy
radical cystectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
Description:
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.
Arm group label:
Participants Who Watch Educational Videos Before Surgery
Arm group label:
Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
Intervention type:
Other
Intervention name:
Geriatric Service/ Discharge Planning
Description:
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.
Arm group label:
Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
Intervention type:
Other
Intervention name:
Questionnaires
Description:
These questionnaires will ask about the participants' mobility, frailty, quality of life
and additional health/risk factors before and after surgery.
Arm group label:
Participants Who Watch Educational Videos Before Surgery
Arm group label:
Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
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.
Criteria for 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)
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago Medicine Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Piyush Agarwal, MD
Phone:
773-702-3080
Start date:
August 9, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
University of Chicago
Agency class:
Other
Source:
University of Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06427824
