NCT02942121

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

October 20, 2016

Last Update Submit

January 30, 2019

Conditions

Keywords

surgery educationradical cystectomycystectomymuscle-invasive bladder cancer

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

EXPERIMENTAL

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

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.

Also known as: LST app
LST App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Eugene Lee, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations