Remote Monitoring for Bladder Cancer
(WATCH Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Remote Monitoring for Bladder Cancer?
Research shows that remote patient monitoring, which involves tracking health data from patients at home, can help manage symptoms and improve recovery in cancer patients undergoing surgery. This approach has been found useful in other types of cancer care, suggesting it could be beneficial for bladder cancer as well.12345
How is the Remote Monitoring treatment for bladder cancer different from other treatments?
Remote Monitoring for bladder cancer is unique because it uses technology to track a patient's health from a distance, allowing for continuous observation without frequent hospital visits. This approach is different from traditional treatments like surgery or radiation, which require direct medical intervention.678910
Research Team
Kathryn Marchetti, MD
Principal Investigator
University of Pittsburgh Medical Center
Eligibility Criteria
This trial is for English-speaking individuals who are undergoing cystectomy at a single center and own a smartphone. It's not open to those unwilling or unable to participate, non-English speakers, or those without a smartphone.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Post-operative Monitoring
Participants receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities trigger automated alerts to providers.
Follow-up
Participants are monitored for safety and effectiveness after the post-operative monitoring period
Treatment Details
Interventions
- Remote Monitoring
Remote Monitoring is already approved in European Union, United States, Canada for the following indications:
- Cardiac Implantable Electronic Devices (CIEDs) management
- Implantable Cardioverter Defibrillator (ICD) monitoring
- Pacemaker (PM) surveillance
- CIEDs management
- ICD monitoring
- PM surveillance
- CIEDs management
- ICD monitoring
- PM surveillance (limited use)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor