Application-based Perioperative Management of the Radical Cystectomy Patient

January 30, 2019 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LST App
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.
Other: LifeScience Technologies application
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.
Other Names:
  • LST app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance using LST app at home
Time Frame: 90 Days
The LST app logs user activity. The study team will track user compliance with completing forms and questions within the application.
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-generated subjective global assessment (PG-SGA)
Time Frame: Baseline
Test the PG-SGA using the LST app to see if it is feasible in practice at identifying patients at increased risk of malnutrition.
Baseline
Edmonton Frail Scale (EFS)
Time Frame: Baseline
Test the EFS using the LST app to see if it is feasible in practice at identifying frail patients.
Baseline
Physician Office/Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Research (HealthStream™)
Time Frame: Change from Baseline to Day 90
Measure of how well the patient understood the various tests and procedures that were discussed with them before and after surgery.
Change from Baseline to Day 90
Count of readmissions
Time Frame: Day 90
Count of the number of readmissions to the hospital.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

University of Kansas

Investigators

  • Principal Investigator: Eugene Lee, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

February 14, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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