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

The University of Chicago

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: Geriatric Service/ Discharge Planning; Other: Questionnaires; Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

Study type: Interventional

Funder types: Other

Identifiers

NCT06427824

IRB23-0773

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Participants Who Watch Educational Videos Before Surgery

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

Other: Questionnaires

Other: Geriatric Service/ Discharge Planning