Back to resultsApplication-based Perioperative Management of the Radical Cystectomy Patient
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LifeScience Technologies application
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Cancer focused on measuring surgery education, radical cystectomy, cystectomy, muscle-invasive bladder cancer
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of recurrent Non-muscle invasive bladder cancer (NMIBC) or Muscle-invasive Bladder Cancer (MIBC) and are candidates for radical cystectomy
- Subjects must have an internet connection and be able and willing to use an applicable device. If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study).
Exclusion Criteria:
- No internet access
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LST App
Arm Description
Participants will use the LifeScience Technologies application (LST app) before surgery, and post surgery. Participants will use the app as an educational tool to learn more about their surgery. Participants will also answer questions about themselves in the app.
Outcomes
Primary Outcome Measures
Compliance using LST app at home
The LST app logs user activity. The study team will track user compliance with completing forms and questions within the application.
Secondary Outcome Measures
Patient-generated subjective global assessment (PG-SGA)
Test the PG-SGA using the LST app to see if it is feasible in practice at identifying patients at increased risk of malnutrition.
Edmonton Frail Scale (EFS)
Test the EFS using the LST app to see if it is feasible in practice at identifying frail patients.
Physician Office/Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Research (HealthStream™)
Measure of how well the patient understood the various tests and procedures that were discussed with them before and after surgery.
Count of readmissions
Count of the number of readmissions to the hospital.
Full Information
NCT ID
NCT02942121
First Posted
October 20, 2016
Last Updated
January 30, 2019
Sponsor
University of Kansas Medical Center
Collaborators
University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT02942121
Brief Title
Application-based Perioperative Management of the Radical Cystectomy Patient
Official Title
Application-based Perioperative Management of the Radical Cystectomy Patient
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of Kansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to learn whether it is feasible to use the LifeScience Technologies application (LST app) in patients undergoing radical cystectomy with the eventual goal to reduce complications and readmissions to the hospital after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
surgery education, radical cystectomy, cystectomy, muscle-invasive bladder cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LST App
Arm Type
Experimental
Arm Description
Participants will use the LifeScience Technologies application (LST app) before surgery, and post surgery. Participants will use the app as an educational tool to learn more about their surgery. Participants will also answer questions about themselves in the app.
Intervention Type
Other
Intervention Name(s)
LifeScience Technologies application
Other Intervention Name(s)
LST app
Intervention Description
Application for mobile devices. The app enables users to review educational videos about a surgery and recovery from a surgery from home. It also enables the user to track different metrics specific to the user's health.
Primary Outcome Measure Information:
Title
Compliance using LST app at home
Description
The LST app logs user activity. The study team will track user compliance with completing forms and questions within the application.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Patient-generated subjective global assessment (PG-SGA)
Description
Test the PG-SGA using the LST app to see if it is feasible in practice at identifying patients at increased risk of malnutrition.
Time Frame
Baseline
Title
Edmonton Frail Scale (EFS)
Description
Test the EFS using the LST app to see if it is feasible in practice at identifying frail patients.
Time Frame
Baseline
Title
Physician Office/Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Research (HealthStream™)
Description
Measure of how well the patient understood the various tests and procedures that were discussed with them before and after surgery.
Time Frame
Change from Baseline to Day 90
Title
Count of readmissions
Description
Count of the number of readmissions to the hospital.
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of recurrent Non-muscle invasive bladder cancer (NMIBC) or Muscle-invasive Bladder Cancer (MIBC) and are candidates for radical cystectomy
Subjects must have an internet connection and be able and willing to use an applicable device. If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study).
Exclusion Criteria:
No internet access
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Lee, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application-based Perioperative Management of the Radical Cystectomy Patient
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