Application-based Perioperative Management of the Radical Cystectomy Patient

Bladder Cancer Clinical Trial

Official title:

Application-based Perioperative Management of the Radical Cystectomy Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942121
• Other study ID #: STUDY00003585
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline
Secondary	Edmonton Frail Scale (EFS)	Test the EFS using the LST app to see if it is feasible in practice at identifying frail patients.	Baseline
Secondary	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.	Change from Baseline to Day 90
Secondary	Count of readmissions	Count of the number of readmissions to the hospital.	Day 90