Donate
Back to Clinical Trials
Back to Clinical Trials

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
  • NCT 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
    Completed
  • Start Date
    March 25, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: 18 Years

Maximum Age: N/A

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: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

Read Our Stories