WATChmAN Virtual Testicular Cancer Clinic

NCT03360994 | Active Not Recruiting

• 1 other identifier: 17-5366
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy

  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.

  December 2017 - December 2026

Secondary Outcomes (3)

• Patient Satisfaction

  December 2017 - December 2026

• Physician Satisfaction

  December 2017 - December 2026

• Clinic Flow Metrics

  December 2017 - December 2026

Study Arms (2)

WATChmAN

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

WATChmAN Active Surveillance OTHER

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.

WATChmAN

In-person Active Surveillance OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 in the last 9 months and will be/are on 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

You may not qualify if:

• Men who have experienced metastatic disease or TCa relapse within their first 9 months of AS
• Men with inadequate computer literacy or compliance as deemed by the study team

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Robert J Hamilton, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: December 15, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)