search
Back to results

Testing the Utilization of a Mobile Health App for Patients Undergoing Cystectomy Surgery for Bladder Cancer

Primary Purpose

Invasive Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health app tool - Twistle
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Invasive Bladder Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Minimum Age: 18 Years Maximum Age: 99 Years Sex: All Gender Based: No

Criteria: Inclusion Criteria:

  • Male or female patients with invasive bladder cancer scheduled for radical cystectomy at UNC within the next 30 days
  • English-speaking
  • Ability to access the Internet (either themselves or with assistance from their caregiver)
  • Ability to read
  • Ability to provide informed consent.

Exclusion Criteria:

  • Inability to read
  • Inability to provide informed consent
  • Severe psychiatric illness
  • Cystectomy surgery without cancer diagnosis
  • Non-English speaking

Sites / Locations

  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health App with Provider Monitoring/Care

Arm Description

30 patients enrolled by the study team will receive notifications through a mobile health app (Twistle) before and after surgery. Patient Reported Outcome data will be collected through patient responses in this app and timely clinician feedback will be provided to patients to prevent complications and readmission.

Outcomes

Primary Outcome Measures

Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly
percentage of patients using the tool at least once weekly

Secondary Outcome Measures

Acceptability of tool (Twistle): Percentage of patients being satisfied or very satisfied with the mobile health tool
Percentage of patients being satisfied or very satisfied with the mobile health tool, determined through an online post-intervention survey, addressing ease of use, convenience, privacy and confidentiality, and willingness to use the tool.

Full Information

First Posted
March 1, 2019
Last Updated
June 11, 2020
Sponsor
UNC Lineberger Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03862105
Brief Title
Testing the Utilization of a Mobile Health App for Patients Undergoing Cystectomy Surgery for Bladder Cancer
Official Title
Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study that involves human subjects undergoing cystectomy surgery for bladder cancer, testing the utilization of a mobile health app that promotes postoperative patient engagement, along with provider monitoring and care. The aim of this pilot study is to assess feasibility and acceptability of an Internet-based mobile health tool following cystectomy discharge. Objectives will be met by assessing weekly adherence, determining acceptability of mobile health questions post-surgery by patients and providers, and by obtaining participant feedback regarding the tool. Complications, re-admissions, and resource utilization will also be monitored throughout the study. The hypothesis is that an mobile health intervention that tracks PROs, provides educational content, and allows real-time feedback via internet-enabled devices has the potential to improve the quality of care delivery and overall patient experience following surgery by decreasing resource utilization and improving symptom control and communication.
Detailed Description
Radical cystectomy will be used as a model to examine the utilization of an electronic, internet-based mobile health intervention that can prospectively collect PRO data while providing timely feedback to patients and clinicians. This mobile health intervention will utilize a well-established platform (Twistle) that can be accessed through multiple technologies, including laptops, smartphones, and other computer-based systems. The objective is to evaluate the feasibility of pre-specified Patient Reported Outcomes and educational content in an existing mobile health communications platform which tracks patient symptoms and provides real-time feedback to patients and providers following cystectomy discharge. Patient Reported Outcome questions and responses will be inputted using validated questions with branching logic to drive feedback based upon responses. The intent of this study is to evaluate feasibility and acceptability of this mobile health tool following cystectomy discharge. Usual care will continue in coordination with this intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Bladder Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health App with Provider Monitoring/Care
Arm Type
Experimental
Arm Description
30 patients enrolled by the study team will receive notifications through a mobile health app (Twistle) before and after surgery. Patient Reported Outcome data will be collected through patient responses in this app and timely clinician feedback will be provided to patients to prevent complications and readmission.
Intervention Type
Other
Intervention Name(s)
Mobile Health app tool - Twistle
Intervention Description
The investigators propose to use radical cystectomy as a model to examine the utilization of an electronic, internet-based mobile health intervention that can prospectively collect Patient Reported Outcome data while providing timely feedback to patients and clinicians. This mobile health intervention will utilize a well-established platform (Twistle) that can be accessed through multiple technologies, including laptops, smartphones, and other computer-based systems.
Primary Outcome Measure Information:
Title
Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly
Description
percentage of patients using the tool at least once weekly
Time Frame
90 days postoperative
Secondary Outcome Measure Information:
Title
Acceptability of tool (Twistle): Percentage of patients being satisfied or very satisfied with the mobile health tool
Description
Percentage of patients being satisfied or very satisfied with the mobile health tool, determined through an online post-intervention survey, addressing ease of use, convenience, privacy and confidentiality, and willingness to use the tool.
Time Frame
90 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Minimum Age: 18 Years Maximum Age: 99 Years Sex: All Gender Based: No Criteria: Inclusion Criteria: Male or female patients with invasive bladder cancer scheduled for radical cystectomy at UNC within the next 30 days English-speaking Ability to access the Internet (either themselves or with assistance from their caregiver) Ability to read Ability to provide informed consent. Exclusion Criteria: Inability to read Inability to provide informed consent Severe psychiatric illness Cystectomy surgery without cancer diagnosis Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela B Smith, MD,MS,FACS
Organizational Affiliation
Associate Professor, Dept of Urology, Director of Urologic Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
UNC Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

Testing the Utilization of a Mobile Health App for Patients Undergoing Cystectomy Surgery for Bladder Cancer

We'll reach out to this number within 24 hrs