Application-based Perioperative Management of the Radical Cystectomy Patient
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFebruary 1, 2019
January 1, 2019
1.5 years
October 20, 2016
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 Days
Secondary Outcomes (4)
Patient-generated subjective global assessment (PG-SGA)
Baseline
Edmonton Frail Scale (EFS)
Baseline
Physician Office/Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Research (HealthStreamâ„¢)
Change from Baseline to Day 90
Count of readmissions
Day 90
Study Arms (1)
LST App
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- No internet access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- University of Kansascollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene Lee, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 21, 2016
Study Start
September 1, 2016
Primary Completion
February 14, 2018
Study Completion
September 30, 2018
Last Updated
February 1, 2019
Record last verified: 2019-01