Use of Wearables Following Cystectomy- Part II

NCT07148765 | Enrolling By Invitation

• 1 other identifier: STUDY25060009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the practical considerations for having health care providers respond in real-time to abnormalities detected remotely for patients recovering from cystectomy following discharge from the hospital. Participants will be asked to wear a wearable fitness tracker (e.g., Fitbit) and answer a daily brief questionnaire on their smartphone. The main question\[s\] the investigators aims to answer are:

• Is it practical to have health care providers respond in real-time to abnormal biomarkers collected using fitness trackers for patients recovering from cystectomy?
• Can we identify early biomarker signatures (e.g. using heart rate, pulse oximetry, respiratory rate, etc.) that can predict adverse events that lead to hospital readmissions? Participants will
• Set up and use a Fitbit Sense 2 device for up to 2 weeks prior to surgery and again for 30 days following discharge after their surgical hospitalization.
• Download and complete questionnaires in a smartphone application for up to 2 weeks prior to surgery and again for 30 days following discharge after their surgical hospitalization.
• Trigger automated alerts when abnormal biometric data (from the Fitbit device) or concerning survey responses are detected.
• Receive contact from a health care provider within 24 hours of an automated alert being generated.

Conditions

Bladder Cancer; Neurogenic Bladder Disorder; Cystectomy

Keywords

Wearable Electronic Devices; Patient Reported Outcome Measures; Postoperative Care; Remote Monitoring; Cystectomy; Urinary Diversion; Fitbit

Outcome Measures

Primary Outcomes (2)

• Proportion of participants who remain in the study from enrollment until trial completion (participant retention)

  From enrollment to 30 days post-discharge following cystectomy hospitalization

• Participant wearable electronic device adherence

  Proportion of patients who wear and transmit data from the provided Fitbit Sense 2 device for at least 16 hours per day for more 14 days

  From day of discharge following cystectomy hospitalization to 30 days post-discharge

Secondary Outcomes (2)

• Number of participants readmitted

  from discharge following cystectomy hospitalization to 30-days post-discharge

• Number of participant unplanned encounters

  From time of discharge following cystectomy hospitalization to 30 days post-discharge

Study Arms (1)

Fitbit Sense 2 + smartphone surveys

EXPERIMENTAL

Participants undergoing remote monitoring following cystectomy using Fitbit sense 2 device for continuous biometric marker collection and transmission and completion of daily PRO questionnaires administered via smartphone application to trigger provider response within 24 hours of predefined threshold abnormalities.

Device: Fitbit Sense 2; Other: Smartphone application survey

Interventions

Fitbit Sense 2 DEVICE

Continuous biometric monitoring (e.g., heart rate, pulse oximetry, respiratory rate, etc.) that will trigger alerts based on predefined threshold criteria for health care providers to respond to by contacting patients within 24 hours of alert.

Fitbit Sense 2 + smartphone surveys

Smartphone application survey OTHER

Daily questionnaire to record PROs will be administered via patient smartphones. Concerning PROs will trigger alerts which health care providers will respond to by contacting patients within 24 hours of alert.

Fitbit Sense 2 + smartphone surveys

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Owns a smartphone
• Scheduled to undergo cystectomy with urinary diversion at a UPMC hospital

You may not qualify if:

• No reliable internet access
• Concurrent enrollment in another interventional study that may interfere with outcomes

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew R Epstein, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available at the time of publication and 7 years following (as data stored at institution for 7 years following project completion).
• Access Criteria: Interested researcher can contact the study team for any purpose. Individual participant data to researchers who provide a methodologically sound proposal. The data will be made available following a data use agreement.

Locations

US (1)