Testing the Utilization of a Mobile Health App for Patients Undergoing Cystectomy Surgery for Bladder Cancer
June 11, 2020 updated by: UNC Lineberger Comprehensive Cancer Center
Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
33
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
-
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North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
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-
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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health App with Provider Monitoring/Care
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly
Time Frame: 90 days postoperative
|
percentage of patients using the tool at least once weekly
|
90 days postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of tool (Twistle): Percentage of patients being satisfied or very satisfied with the mobile health tool
Time Frame: 90 days postoperative
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Angela B Smith, MD,MS,FACS, Associate Professor, Dept of Urology, Director of Urologic Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
March 25, 2019
Primary Completion (Actual)
April 27, 2020
Study Completion (Actual)
April 27, 2020
Study Registration Dates
First Submitted
March 1, 2019
First Submitted That Met QC Criteria
March 4, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 12, 2020
Last Update Submitted That Met QC Criteria
June 11, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1856
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.