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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03862105
Other study ID # LCCC1856
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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