Bladder Cancer
Conditions
Keywords
cystectomy, radical cystectomy
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.
Interventions
OTHEREducational 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.
OTHERGeriatric Service/ Discharge Planning
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.
OTHERQuestionnaires
These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Referred to Educational Program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey responses from participants who completed some or all of educational program | 90 days | 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. |
| Number of self-reported interventions/strategies used among participants after watching educational videos | 90 days | 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 |
| 30-day Hospital Readmission Rates Among All Participants | 30 days | Assess impact of educational program by comparing the differences between hospital readmission rate at 30 days between both study cohorts. |
| 90-day Hospital Readmission Rates Among All Participants | 90 days | Assess impact of educational program by comparing the differences between hospital readmission rate at 90 days between both study cohorts. |
| Complication Rates Reported Among Participants | 90 days | Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups. |
Countries
United States
Contacts
Primary ContactPiyush K Agarwal, MD
Outcome results
None listed