Virtual Active Surveillance for Testicular Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastatic disease, TCa relapse, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual platform called WATChmAN for follow-up care in men with stage 1 testicular cancer. The goal is to determine if online check-ins can replace frequent clinic visits while still effectively monitoring the cancer. Patients will either continue with standard in-person visits or use the WATChmAN virtual system to manage their care from home. Eligible participants should have undergone surgery for testicular cancer in the past nine months and be under active surveillance, with the ability to use digital devices for communication. The trial aims to make follow-up more convenient and less costly, improving satisfaction without compromising safety. As an unphased trial, this study provides a unique opportunity to contribute to innovative care solutions that could enhance convenience and satisfaction for future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the WATChmAN virtual platform is safe for testicular cancer follow-up?

Research has shown that the WATChmAN virtual testicular cancer clinic is designed to replace some in-person visits with online care. This system aims to help patients manage their follow-up care for testicular cancer more easily and from the comfort of their own homes.

While specific studies on the safety of the virtual platform itself are not detailed, the technology is part of a controlled trial, which focuses on safety and effectiveness. The trial's "not applicable" phase indicates it is not testing a new drug, but rather a change in how care is provided. This usually means the main concern is not the safety of a drug, but how the new service model affects patient care.

In conclusion, the WATChmAN platform offers a new way to manage care that could be safer and more convenient by improving how patients access their test results and communicate with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional in-person active surveillance for testicular cancer, the WATChmAN Virtual Testicular Cancer Clinic leverages the convenience of online healthcare. This innovative approach allows patients to access their test results and manage appointments through a virtual platform, eliminating the need for frequent clinic visits. Researchers are excited about this trial because it could significantly enhance patient comfort and accessibility, potentially leading to more consistent monitoring and earlier detection of changes in patient health. This method maintains the rigorous testing schedule of standard care while offering a more flexible and patient-friendly experience.

What evidence suggests that the WATChmAN Virtual Testicular Cancer Clinic is effective for testicular cancer follow-up?

Research has shown that virtual platforms like WATChmAN, which participants in this trial may receive, effectively manage follow-up care for testicular cancer patients. This system allows patients to complete check-ups online rather than visiting the clinic in person. Studies have found that virtual care increases patient satisfaction and adherence to follow-up schedules. It also reduces the costs and stress associated with frequent clinic visits. By tracking test results and appointments online, patients can detect early signs of cancer recurrence, enabling timely treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert Hamilton, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for men over 18 who can understand English, have access to a digital device, and have had stage 1 testicular cancer treated with orchiectomy within the last 9 months. They should be ready to follow a strict check-up schedule. Men with metastatic disease or relapse in the first 9 months, or poor computer skills as judged by the study team cannot join.

Inclusion Criteria

I had surgery to remove a testicle due to cancer and am being closely monitored.

Must be prepared to comply with the close follow-up protocol and provide informed consent

Have access to an electronic platform (i.e. computer, smart phone, tablet, etc.)

Exclusion Criteria

My cancer spread or came back within 9 months of starting active surveillance.

The study team considers my computer skills or ability to follow the study plan as inadequate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Surveillance

Participants undergo active surveillance with blood work and imaging at regular intervals to detect relapse at a curable stage

5-9 years

Multiple visits over 5-9 years, both in-person and virtual

Follow-up

Participants are monitored for safety and effectiveness after active surveillance

4 weeks

Virtual Platform Development

Development and implementation of the WATChmAN virtual platform for testicular cancer follow-up

1 year

What Are the Treatments Tested in This Trial?

Interventions

• WATChmAN Virtual Testicular Cancer Clinic

Trial Overview The WATChmAN project is testing a web-based virtual clinic against traditional in-person visits for monitoring testicular cancer patients under active surveillance. The goal is to see if online follow-ups can improve patient satisfaction and adherence while reducing costs.

How Is the Trial Designed?

Group I: WATChmAN Experimental Treatment 1 Intervention

Patients randomized to the WATChmAN Active Surveillance arm will receive their active surveillance testicular cancer care via an online virtual clinic. Importantly, patients will follow the same surveillance schedule as patients in the standard of care arm. However, patients in the WATChmAN arm will be able to see their upcoming tests and virtual appointments online, request requisitions to perform their required testing at outside institutions, and indicate any concerns for physicians to review during the virtual visit.

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to the standard of care arm (in-person active surveillance) will follow the current active surveillance protocol in place at Princess Margaret Cancer Centre's Multidisciplinary Testicular Cancer Clinic. This protocol involves the same schedule of testing as the WATChmAN arm, but will require patients to come into the clinic to receive their test results (as in current practice).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2020.38.6_suppl.396

WATChmAN: A randomized trial of virtual surveillance ... We are conducting an RCT (NCT03360994) where patients with stage I TC on AS are randomized to virtual care (WATChmAN), or standard in-person care.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03360994

NCT03360994 | WATChmAN Virtual Testicular Cancer Clinic Princess Margaret's Multidisciplinary Testicular Cancer (TCa) Clinic sees over 25% of Ontario's testicular cancer patients, many of whom travel long ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10560341/

innovations in testicular cancer care - PMC Matulewicz et al. (5) discussed the Web-based virtuAl Testicular CANcer (WATChmAN) randomized controlled trial comparing in-person care to virtual care.

4. withpower.com withpower.com/trial/phase-testicular-neoplasms-11-2017-f2ca2

Virtual Active Surveillance for Testicular Cancer This trial is testing WATChmAN, an online system for testicular cancer patients to manage their follow-up care virtually. It aims to make follow-ups easier ...

5. researchgate.net researchgate.net/publication/339388035_WATChmAN_A_randomized_trial_of_virtual_surveillance_versus_standard_in-person_care_for_clinical_stage_I_testicular_cancer

A randomized trial of virtual surveillance versus standard in ... We innovated a secure online platform, WATChmAN (Web-based virtuAl Testicular CANcer clinic) allowing asynchronous communication between patients, results, and ...

6. journals.lww.com journals.lww.com/auajuro/abstract/2020/04001/pd19_03_watchman__a_randomized_trial_of_virtual.817.aspx

PD19-03 WATCHmAN We innovated a secure online platform, WATChmAN (Web-based virtuAl Testicular CANcer clinic) allowing asynchronous communication between patients, results, and ...