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WATChmAN Virtual Testicular Cancer Clinic

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ClinicalTrials.gov Identifier: NCT03360994
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Princess Margaret's Multidisciplinary Testicular Cancer (TCa) Clinic sees over 25% of Ontario's testicular cancer patients, many of whom travel long distances. Fortunately, the majority of cases are confined to the testicle and are managed by "active surveillance" (AS), whereby blood work and imaging at regular intervals look to detect relapse at a curable stage. This currently requires multiple clinic visits over 5-9 years. This follow-up can be time-consuming, costly, difficult to adhere to and unsatisfying for patients. The goal of this project is to develop an efficient technological platform to perform virtual cancer follow-up. The platform has been named, "WATChmAN" which stands for Web-based virtual Testicular CANcer clinic. It will provide a secure, online interface to all virtual follow-up visits as an alternative to costly and time-consuming travel for in-person visits. The investigators anticipate improved patient satisfaction and dramatic reductions in the cost of cancer care follow-up. Moreover, the investigators anticipate improved compliance, which will lead to safer care. While TCa serves as the working platform, the investigators envision the end-product to be scalable and generalizable to other cancers (e.g. prostate cancer surveillance) across the province.

Condition or disease Intervention/treatment
Testicular Cancer Other: WATChmAN Active Surveillance Other: In-person Active Surveillance

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: WATChmAN
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: December 2017 - December 2024 ]
    Assess patient satisfaction with receiving their care virtually and with the system that administers the care.

  2. Physician Satisfaction [ Time Frame: December 2017 - December 2024 ]
    Assess physician satisfaction with delivering care virtually and with the system that administers the care.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men who are at least 18 years of age
  • Can read, write, and speak English
  • Have access to an electronic platform (i.e. computer, smart phone, tablet, etc.)
  • Have had histologically confirmed stage 1 testicular cancer (seminoma or non- seminoma),
  • Have undergone a radical orchiectomy and going to be/are within their first 6 months of active surveillance under the supervision of the multidisciplinary testicular cancer clinic at Princess Margaret.
  • Must be prepared to comply with the close follow-up protocol and provide informed consent

Exclusion Criteria:

  • Men who have experienced metastatic disease or TCa relapse within their first 6 months of AS
  • Men with inadequate computer literacy or compliance as deemed by the study team
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Robert J Hamilton, MD 416-946-2909 rob.hamilton@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Robert Hamilton, MD    416-946-2909      
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Robert J Hamilton, MD University Health Network--Princess Margaret Cancer Centre
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03360994     History of Changes
Other Study ID Numbers: 17-5366
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders