Bladder CancerWATCHNCT06397040
The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
A study testing provider monitoring and feedback to remote data and participant monitoring of remote data in people with Bladder Cancer and Quality of Life, run by University of Pittsburgh at 1 site in United States.
Trial summary
Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Quality of Life
- What is being tested?
- provider monitoring and feedback to remote data and participant monitoring of remote data
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing cystectomy at three hospitals within the University of Pittsburgh Medical Center system
- English speaking
- owns smart phone
Who cannot join
- unwilling or unable to participate
- non-English speaking
- does not own smart phone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. By gathering biomarkers passively and continuously, wearable activity monitors augment remote patient monitoring. Further, they facilitate the collection of patient-reported outcomes frequently.
Despite the proven impact of remote monitoring on patient care, there is limited data on the feasibility and impact of employing this technology to trigger real-time provider assessment following cystectomy. The investigators plan to conduct a randomized control trial examining such. The intervention group of participants will receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities in remote data will trigger automated alerts to providers. Providers will respond in real-time to these alerts and patients will receive education materials discussing preventative measures to mitigate the main risk factors for readmissions. The investigators will evaluate the feasibility of integrating this technology into the post-operative period, as well as the impact of real-time provider attention to abnormal remote data on patient-reported outcomes and rates of readmission. The investigators hypothesize that early assessment of and intervention on remote abnormalities will promote the use of outpatient or reduced intensity therapies, such as oral antibiotics or oral hydration, thus curtailing the severity of patient symptoms, intensity of complications, and need for hospitalizations. Ultimately, this trial builds upon prior research, applying patient-centered technology to improve the quality of care following cystectomy.
- Conditions
- Bladder Cancer, Quality of Life
- Being tested
- provider monitoring and feedback to remote data, participant monitoring of remote data
- Keywords
- bladder cancer, remote monitoring, quality of life, cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provider monitoring and feedback to remote dataDevice
provider monitoring of remote data and feedback to changes in remote data
participant monitoring of remote dataDevice
participant monitoring of remote data, based upon post-operative instructions
| Study group | Role | What they receive |
|---|---|---|
| remote monitoring without provider feedback | Experimental | remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback Receives: Device: participant monitoring of remote data |
| remote monitoring with provider feedback | Experimental | remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data Receives: Device: provider monitoring and feedback to remote data; Device: participant monitoring of remote data |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient engagement
percent of patients who utilized the application daily and wore the device for 8hrs daily
Measured: 4 weeks following hospital discharge
provider response
time from alert to provider response to patient
Measured: 4 weeks following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Jacobs, University of Pittsburgh
- Investigators
- Kathryn Marchetti, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397040
- Sponsor's protocol ID
- STUDY23110094
- Acronym
- WATCH
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
- ClinicalTrials.gov ID
- NCT06397040
- Acronym / sponsor ID
- WATCH / STUDY23110094
- Conditions
- Bladder Cancer, Quality of Life
- Keywords
- bladder cancer, remote monitoring, quality of life, cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. By gathering biomarkers passively and continuously, wearable activity monitors augment remote patient monitoring. Further, they facilitate the collection of patient-reported outcomes frequently.
Despite the proven impact of remote monitoring on patient care, there is limited data on the feasibility and impact of employing this technology to trigger real-time provider assessment following cystectomy. The investigators plan to conduct a randomized control trial examining such. The intervention group of participants will receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities in remote data will trigger automated alerts to providers. Providers will respond in real-time to these alerts and patients will receive education materials discussing preventative measures to mitigate the main risk factors for readmissions. The investigators will evaluate the feasibility of integrating this technology into the post-operative period, as well as the impact of real-time provider attention to abnormal remote data on patient-reported outcomes and rates of readmission. The investigators hypothesize that early assessment of and intervention on remote abnormalities will promote the use of outpatient or reduced intensity therapies, such as oral antibiotics or oral hydration, thus curtailing the severity of patient symptoms, intensity of complications, and need for hospitalizations. Ultimately, this trial builds upon prior research, applying patient-centered technology to improve the quality of care following cystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote monitoring without provider feedback | Experimental | Device: participant monitoring of remote dataremote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback |
| remote monitoring with provider feedback | Experimental | Device: provider monitoring and feedback to remote data, Device: participant monitoring of remote dataremote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing cystectomy at three hospitals within the University of Pittsburgh Medical Center system
- English speaking
- owns smart phone
Key exclusion criteria (3 listed)
- unwilling or unable to participate
- non-English speaking
- does not own smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provider monitoring and feedback to remote dataprovider monitoring of remote data and feedback to changes in remote data | Device | remote monitoring with provider feedback |
| participant monitoring of remote dataparticipant monitoring of remote data, based upon post-operative instructions | Device | remote monitoring with provider feedback, remote monitoring without provider feedback |
Primary outcome
patient engagement
Time frame: 4 weeks following hospital discharge
percent of patients who utilized the application daily and wore the device for 8hrs daily
provider response
Time frame: 4 weeks following hospital discharge
time from alert to provider response to patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Marchetti, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing provider monitoring and feedback to remote data and participant monitoring of remote data in people with Bladder Cancer and Quality of Life, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient engagement (time frame: 4 weeks following hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.