WATChmAN Virtual Testicular Cancer Clinic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03360994|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Testicular Cancer||Other: WATChmAN Active Surveillance Other: In-person Active Surveillance||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the WATChmAN (Web virtuAl Testicular CANcer Clinic): A Randomized Controlled Study to Estimate the Efficacy of an Electronic Surveillance Tool for Stage I Testicular Cancer|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 1, 2024|
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.
Other: WATChmAN Active Surveillance
WATChmAN Active Surveillance uses an electronic tool used to provide active surveillance care to testicular cancer patients. This virtual active surveillance care is delivered with an identical schedule to in-person care without the need to come into clinic.
Active Comparator: Standard of Care
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).
Other: In-person Active Surveillance
In-person active surveillance is the current recommended management option for all Stage I testicular cancer patients at Princess Margaret. Patients are monitored clinically with imaging and blood work, and active treatment only begins if relapse occurs.
- Safety and Efficacy [ Time Frame: December 2017 - December 2024 ]Assess the safety and efficacy of administering active surveillance for testicular cancer on a virtual platform. Specifically, patient compliance, relapse incidence, extent of relapse, burden of treatment for relapse, modes of therapy required for relapse, and distal cancer outcomes.
- Patient Satisfaction [ Time Frame: December 2017 - December 2024 ]Assess patient satisfaction with receiving their care virtually and with the system that administers the care.
- Physician Satisfaction [ Time Frame: December 2017 - December 2024 ]Assess physician satisfaction with delivering care virtually and with the system that administers the care.
- Clinic Flow Metrics [ Time Frame: December 2017 - December 2024 ]Assess how implementation of the WATChmAN virtual clinic has impacted the number of new patients seen in clinic, the CCO Wait 1 times (time from receipt of referral to first consult), physician estimations of time spent on follow-up, and examination of lost-to-follow-up rates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360994
|Contact: Robert J Hamilton, MDemail@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Robert Hamilton, MD 416-946-2909|
|Principal Investigator:||Robert J Hamilton, MD||University Health Network--Princess Margaret Cancer Centre|