Remote Monitoring for Bladder Cancer

(WATCH Trial)

Overseen By Bruce Jacobs, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speaking, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for bladder cancer patients who have undergone a cystectomy (bladder removal surgery). Researchers seek to determine if remote monitoring, using wearable devices like FitBits, can detect complications early and reduce hospital readmissions. The trial will compare two groups: one with only monitoring and another with monitoring plus real-time feedback from healthcare providers. Ideal candidates for this trial have had a cystectomy at a University of Pittsburgh Medical Center hospital, speak English, and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance recovery and reduce complications.

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 prior data suggests that this remote monitoring technology is safe for post-operative bladder cancer patients?

Research has shown that remote monitoring is generally safe and well-received by patients. In one study, 95% of veterans with urological conditions expressed satisfaction with remote care, appreciating the technology's ease and convenience. Another study found that smartphones and wearable devices effectively track symptoms and health data for bladder cancer patients.

These findings suggest that remote monitoring, such as using FitBits and smartphones to track health after bladder surgery, is safe. Patients have successfully used similar technology without major issues, providing reassurance about the safety and comfort of participating in such a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote monitoring for bladder cancer because it offers a unique approach to managing the condition. Traditional treatments usually involve regular in-person visits for monitoring, which can be inconvenient and stressful for patients. This innovative technique uses a FitBit device to track patient data daily, providing a more seamless and continuous monitoring experience. One version of the protocol includes real-time feedback from healthcare providers based on the remote data, potentially enhancing patient outcomes by allowing for quicker interventions. This method could transform how bladder cancer is managed by making it more patient-friendly and responsive.

What evidence suggests that remote monitoring is effective for improving post-operative care in bladder cancer patients?

Research has shown that remote monitoring can greatly improve patient care after bladder cancer surgery. In this trial, participants will join one of two groups: one will experience remote monitoring without provider feedback, while the other will receive remote monitoring with provider feedback. One study found that 94.6% of patients felt better within two weeks when their symptoms were monitored remotely. Patients find this technology easy to use and are very satisfied with it. When healthcare providers respond to alerts from the system, symptom management improves further. This type of monitoring helps catch problems early, reducing the need for hospital readmission. Overall, evidence is promising that remote monitoring can enhance recovery and reduce complications after surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Kathryn Marchetti, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

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

English speaking

Owns smart phone

I am scheduled for bladder removal surgery at one hospital.

Exclusion Criteria

Does not own smart phone

I am willing and able to participate in the trial.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the post-operative monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Monitoring

Trial Overview The study tests if remote monitoring with FitBits and smartphones can improve care after bladder cancer surgery. Participants will be randomly assigned to either get continuous biomarker monitoring and daily health reports, with provider alerts for any issues, or standard post-operative care.

How Is the Trial Designed?

Group I: remote monitoring without provider feedback Experimental Treatment 1 Intervention

remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback

Group II: remote monitoring with provider feedback Experimental Treatment 2 Interventions

remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data

Remote Monitoring is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Remote Monitoring for:

• Cardiac Implantable Electronic Devices (CIEDs) management
• Implantable Cardioverter Defibrillator (ICD) monitoring
• Pacemaker (PM) surveillance

Approved in United States as Remote Monitoring for:

• CIEDs management
• ICD monitoring
• PM surveillance

Approved in Canada as Remote Monitoring for:

• CIEDs management
• ICD monitoring
• PM surveillance (limited use)

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Remote patient monitoring software (RPMS) in oncology care significantly improves health-related quality of life and reduces physical symptom burden during cancer treatment, based on a review of nine randomized controlled trials.

The effectiveness of RPMS is enhanced when integrated into routine clinical care, particularly with nurses involved in remote monitoring, indicating that this model can be a valuable addition to standard cancer care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Patient-Reported Outcome Tracking and Health Information Provision via Remote Patient Monitoring Software on Patient Outcomes in Oncology Care: A Systematic Review and Meta-Analysis. Wang, T., Ho, MH., Tong, MCF., et al.[2023]

A study involving 21 complex general and urologic oncology surgery patients showed that remote telemonitoring of health data and patient-reported outcomes is feasible, with high adherence rates of 95% before surgery and 91% at discharge.

Despite high adherence, patients experienced significant declines in mobility and daily activities shortly after discharge, indicating the need for ongoing support and monitoring in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology. Melstrom, LG., Zhou, X., Kaiser, A., et al.[2023]

Out of 465 patients starting systemic cancer treatment, 51.4% expressed interest in using a remote system for daily symptom monitoring, indicating a good level of acceptance for this technology.

The system demonstrated a compliance rate of 68.8% in the first 3 weeks and 59.1% by 12 weeks, suggesting that daily monitoring is feasible; however, many patients felt their reports were not adequately utilized by healthcare providers, highlighting an area for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote System for Daily Symptom Monitoring During Systemic Anticancer Treatment: Patient Acceptance, Usability, and Compliance. Coolbrandt, A., Muylaert, K., Vandeneede, E., et al.[2022]

Remote patient monitoring using patient-generated health data can help assess and improve recovery for cancer patients undergoing complex urologic and gynecologic surgeries.

This integrative review highlights the potential benefits of remote monitoring in addressing postoperative symptoms and functional declines, although specific data on the effectiveness and implementation are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative review of remote patient monitoring in gynecologic and urologic surgical oncology. Perez, F., Nolde, M., Crane, TE., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541960/

BlaCancer: a mobile health solution for enhancing bladder ... Similarly, a study involving veterans with urological conditions reported that 95% were satisfied with remote management, particularly due to ...

2. ascopubs.org ascopubs.org/doi/10.1200/CCI.24.00092

Remote Patient Monitoring Using Mobile Health ... This study aimed to gain insight into patients' perspectives and preferences for participating in mHealth-based monitoring in cancer care.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10316518/

Mobile Postoperative Symptom Intervention Tool and ... Using smartphone and wearable technology to capture patient-reported symptoms and biometric data is feasible and rated as highly usable by bladder cancer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143921001794

The role of technology in the perioperative management ... The role of technology in the perioperative management of bladder cancer patients ... Digitally-Enabled Remote Care for Cancer Patients: Here to Stay.

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00172-8/fulltext

Implementation of a remote symptom monitoring pathway ... The RPM pathway enabled effective and timely symptom management with 94.6% of all alerts (10,132/10,711) evolving to an improvement two weeks ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-03377

Remote Telemonitoring: Patient Data & Outcomes - NCI This study examines at-home monitoring of patient-generated physiologic health data and patient-reported outcomes.