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

NCT ID: NCT03862105

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-04-27

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.

Conditions

Invasive Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile Health app tool - Twistle

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela B Smith, MD,MS,FACS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Dept of Urology, Director of Urologic Oncology

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

UNC Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC1856

Identifier Type: -

Identifier Source: org_study_id