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

Invasive Bladder Cancer Clinical Trial

Official title:

Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862105
• Other study ID #: LCCC1856
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: June 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Mobile Health app tool - Twistle
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.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days postoperative
Secondary	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.	90 days postoperative

External Links

•   UNC Lineberger Comprehensive Cancer Center Clinical Trials