Bladder Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

33

Study ID:

NCT03862105

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill North Carolina, 27599, United States

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Study is for people with:

Bladder Cancer

Estimated Enrollment:

33

Study ID:

NCT03862105

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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