NCT03862105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

March 1, 2019

Last Update Submit

June 11, 2020

Conditions

Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability of tool (Twistle): Percentage of patients being satisfied or very satisfied with the mobile health tool

    90 days postoperative

Study Arms (1)

Health App with Provider Monitoring/Care

EXPERIMENTAL

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.

Other: Mobile Health app tool - Twistle

Interventions

Mobile Health app tool - TwistleOTHER

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.

Health App with Provider Monitoring/Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to read
  • Inability to provide informed consent
  • Severe psychiatric illness
  • Cystectomy surgery without cancer diagnosis
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

Study Officials

  • Angela B Smith, MD,MS,FACS

    Associate Professor, Dept of Urology, Director of Urologic Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

March 25, 2019

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)