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

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

INTRODUCTION

  • Org Study ID: LCCC1856
  • Secondary ID: N/A
  • NTC ID: NCT03862105
  • Sponsor: UNC Lineberger Comprehensive Cancer Center

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.


  • Overall Status
    Recruiting
  • Start Date
    March 25, 2019
  • Phase
    N/A
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly

Primary Outcome 1 - Timeframe: 90 days postoperative

CONDITION

  • Invasive Bladder Cancer

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

Gender: All

Minimum Age: 100 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Angela B Smith, MD,MS,FACS

Role: Principal Investigator

Affiliation: Associate Professor, Dept of Urology, Director of Urologic Oncology

Overall Contact

Name: Angela B Smith, MD,MS,FACS

Phone: 919-962-4671

Email: dana_mueller@med.unc.edu

LOCATION

Facility Status Contact
Facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact:
Angela B Smith, MD
984-974-1315
angela_smith@med.unc.edu