Bladder CancerNCT06427824
Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy
A study testing Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Geriatric Service/ Discharge Planning and Questionnaires in people with Bladder Cancer, run by University of Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Geriatric Service/ Discharge Planning and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Radical cystectomy for non-oncologic indications
- Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60615
Piyush Agarwal, MD, 773-702-3080
About this study
Official title: Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Geriatric Service/ Discharge Planning, Questionnaires
- Keywords
- cystectomy, radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Geriatric Service/ Discharge PlanningOther
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.
QuestionnairesOther
These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery); Other: Geriatric Service/ Discharge Planning; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (5)
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.
Measured: 90 days
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
Measured: 90 days
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.
Measured: 30 days
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.
Measured: 90 days
Complication Rates Reported Among Participants
Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start9 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piyush Agarwal, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427824
- Sponsor's protocol ID
- IRB23-0773
- Status last verified
- Sep 2025
- First submitted
- 15 May 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06427824
- Acronym / sponsor ID
- IRB23-0773
- Conditions
- Bladder Cancer
- Keywords
- cystectomy, radical cystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Who Watch Educational Videos Before Surgery | Experimental | Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Other: QuestionnairesParticipants 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. |
| Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services | Experimental | Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Other: Geriatric Service/ Discharge Planning, Other: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Radical cystectomy for non-oncologic indications
- Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Participants Who Watch Educational Videos Before Surgery, Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services |
| Geriatric Service/ Discharge PlanningA 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. | Other | Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services |
| QuestionnairesThese questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery. | Other | Participants Who Watch Educational Videos Before Surgery, Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services |
Primary outcome
Number of Participants Referred to Educational Program
Time frame: 90 days
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.
5 secondary outcomes
Survey responses from participants who completed some or all of educational program
Time frame: 90 days
Number of self-reported interventions/strategies used among participants after watching educational videos
Time frame: 90 days
30-day Hospital Readmission Rates Among All Participants
Time frame: 30 days
90-day Hospital Readmission Rates Among All Participants
Time frame: 90 days
Complication Rates Reported Among Participants
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piyush Agarwal principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery), Geriatric Service/ Discharge Planning and Questionnaires in people with Bladder Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piyush K Agarwal, MD (773-702-3080, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Referred to Educational Program (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.