Testicular CancerNCT03360994
WATChmAN Virtual Testicular Cancer Clinic
A study testing WATChmAN Active Surveillance and In-person Active Surveillance in people with Testicular Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- WATChmAN Active Surveillance and In-person Active Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2017to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Patients randomized to the standard of care arm will be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. This involves blood marker and CT tests at predetermined intervals for 5-9 years depending on the patient's testicular cancer diagnosis (seminoma vs. non-seminoma). If randomized to this group, participants will be required to return to the Multidisciplinary Testicular Cancer Clinic to receive the results of their surveillance testing face-to-face in a medical appointment. In addition to these surveillance testing and follow-up visits, participants will also be asked to complete surveys regarding their satisfaction with the in-person active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins. As per current standard of care practice, participants may choose to have their imaging completed at a centre outside of the UHN. In these cases, participants will be required to obtain and send CDs with their imaging and reports to their most responsible oncologist at Princess Margaret. Blood marker visits can be performed anywhere without sending the results to Princess Margaret.
Patients randomized to the WATChmAN group will also be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. If randomized to this group, a physician from the Multidisciplinary Testicular Cancer Clinic will still review the participant's surveillance testing results but will interact with the WATChmAN platform instead of receiving their results face-to-face in a medical appointment. Specifically, if randomized to this group participants will be required to:
- Asked, but not required, to have their picture taken to be uploaded into the WATChmAN platform. Their photo will only be stored on the password-protected WATChmAN database and will serve to cue facial recognition in the physicians reviewing their results and therefore enhance recall of their personal history.
- Confirm their registration in the WATChmAN program via a welcome email
- Respond to WATChmAN generated messages and reminders requesting whether or not their upcoming surveillance testing (e.g. blood tests and/or CT imaging scans) has been completed
- Respond to WATChmAN generated messages to confirm where their upcoming testing (e.g. blood tests and/or CT imaging scans) has been completed
- Check their results on the WATChmAN platform and express any concerns/issues they might have about their treatment and/or health to their most responsible oncologist through the WATChmAN platform
- Confirm receipt of messages concerning whether they need or do not need to come in for an in-person follow up visit
- Return to the Multidisciplinary Testicular Cancer Clinic to see a physician face-to-face for a final exit follow-up appointment when their active surveillance treatment is complete
- If getting their CT imaging visits outside the UHN, obtain and send CDs with their imaging and reports to the WATChmAN research coordinator for upload into the WATChmAN system (please note: this requirement is identical for patients in the standard of care group)
- Participants do not need to send in their blood test results. Their blood marker visits can be performed anywhere without needing to send them to the WATChmAN coordinator.
Finally, in addition to these surveillance testing and WATChmAN interactions, participants will also be asked to complete surveys regarding their satisfaction with their virtual active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins.
It is predicted that the WATChmAN virtual platform will take at least one year to construct; however, the researchers involved in this study believe there is value in launching this virtual clinic without delay. This will also allow further improvements to the design of the WATChmAN platform as it is being built. Therefore, this study will be divided into two stages:
Stage I: During this stage, a clinical research coordinator alongside a nurse from the Genitourinary Clinic at the Princess Margaret Cancer Centre will manually perform all the anticipated functions of the WATChmAN platform. The clinical research coordinator will be responsible for all the administrative roles of WATChmAN including sending appointment reminders and scheduling follow-up virtual appointments. The nurse will be responsible for all the clinical functionalities of the WATChmAN platform. They will manually track patients' blood and imaging test results and work closely with the Multidisciplinary Testicular Cancer Clinic physicians to ensure that all patient surveillance results are reviewed. Patients randomized to the in-person AS group will receive the traditional standard of care which includes returning to clinic to meet with physicians face-to-face to receive imaging and blood testing results.
Stage II: During stage 2 of this investigation, the WATChmAN platform will be responsible for automatically populating the virtual clinic with blood and imaging results, sending appointment reminders and scheduling follow up appointments. The responsibilities of patients randomized to the WATChmAN group will be to acknowledge these email/text appointment reminders (i.e. yes/no to being aware of upcoming appointments), checking their results virtually and scheduling follow-up appointments through the WATChmAN platform. The research coordinator and nurse will continue to oversee the WATChmAN function but will not be manually collating surveillance results (markers/imaging etc.). Patients randomized to the in-person AS group receive the traditional standard of care, returning to the clinic to meet with a physician face-to-face to receive their surveillance imaging and blood marker results.
- Conditions
- Testicular Cancer
- Being tested
- WATChmAN Active Surveillance, In-person Active Surveillance
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATChmAN Active SurveillanceOther
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.
In-person Active SurveillanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: In-person Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2017 - December 2026
Secondary outcomes (3)
Patient Satisfaction
Assess patient satisfaction with receiving their care virtually and with the system that administers the care.
Measured: December 2017 - December 2026
Physician Satisfaction
Assess physician satisfaction with delivering care virtually and with the system that administers the care.
Measured: December 2017 - December 2026
Clinic Flow Metrics
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.
Measured: December 2017 - December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start15 Dec 2017
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Hamilton, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360994
- Sponsor's protocol ID
- 17-5366
- Status last verified
- Aug 2024
- First submitted
- 27 Nov 2017
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03360994
- Acronym / sponsor ID
- 17-5366
- Conditions
- Testicular Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients randomized to the standard of care arm will be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. This involves blood marker and CT tests at predetermined intervals for 5-9 years depending on the patient's testicular cancer diagnosis (seminoma vs. non-seminoma). If randomized to this group, participants will be required to return to the Multidisciplinary Testicular Cancer Clinic to receive the results of their surveillance testing face-to-face in a medical appointment. In addition to these surveillance testing and follow-up visits, participants will also be asked to complete surveys regarding their satisfaction with the in-person active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins. As per current standard of care practice, participants may choose to have their imaging completed at a centre outside of the UHN. In these cases, participants will be required to obtain and send CDs with their imaging and reports to their most responsible oncologist at Princess Margaret. Blood marker visits can be performed anywhere without sending the results to Princess Margaret.
Patients randomized to the WATChmAN group will also be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. If randomized to this group, a physician from the Multidisciplinary Testicular Cancer Clinic will still review the participant's surveillance testing results but will interact with the WATChmAN platform instead of receiving their results face-to-face in a medical appointment. Specifically, if randomized to this group participants will be required to:
- Asked, but not required, to have their picture taken to be uploaded into the WATChmAN platform. Their photo will only be stored on the password-protected WATChmAN database and will serve to cue facial recognition in the physicians reviewing their results and therefore enhance recall of their personal history.
- Confirm their registration in the WATChmAN program via a welcome email
- Respond to WATChmAN generated messages and reminders requesting whether or not their upcoming surveillance testing (e.g. blood tests and/or CT imaging scans) has been completed
- Respond to WATChmAN generated messages to confirm where their upcoming testing (e.g. blood tests and/or CT imaging scans) has been completed
- Check their results on the WATChmAN platform and express any concerns/issues they might have about their treatment and/or health to their most responsible oncologist through the WATChmAN platform
- Confirm receipt of messages concerning whether they need or do not need to come in for an in-person follow up visit
- Return to the Multidisciplinary Testicular Cancer Clinic to see a physician face-to-face for a final exit follow-up appointment when their active surveillance treatment is complete
- If getting their CT imaging visits outside the UHN, obtain and send CDs with their imaging and reports to the WATChmAN research coordinator for upload into the WATChmAN system (please note: this requirement is identical for patients in the standard of care group)
- Participants do not need to send in their blood test results. Their blood marker visits can be performed anywhere without needing to send them to the WATChmAN coordinator.
Finally, in addition to these surveillance testing and WATChmAN interactions, participants will also be asked to complete surveys regarding their satisfaction with their virtual active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins.
It is predicted that the WATChmAN virtual platform will take at least one year to construct; however, the researchers involved in this study believe there is value in launching this virtual clinic without delay. This will also allow further improvements to the design of the WATChmAN platform as it is being built. Therefore, this study will be divided into two stages:
Stage I: During this stage, a clinical research coordinator alongside a nurse from the Genitourinary Clinic at the Princess Margaret Cancer Centre will manually perform all the anticipated functions of the WATChmAN platform. The clinical research coordinator will be responsible for all the administrative roles of WATChmAN including sending appointment reminders and scheduling follow-up virtual appointments. The nurse will be responsible for all the clinical functionalities of the WATChmAN platform. They will manually track patients' blood and imaging test results and work closely with the Multidisciplinary Testicular Cancer Clinic physicians to ensure that all patient surveillance results are reviewed. Patients randomized to the in-person AS group will receive the traditional standard of care which includes returning to clinic to meet with physicians face-to-face to receive imaging and blood testing results.
Stage II: During stage 2 of this investigation, the WATChmAN platform will be responsible for automatically populating the virtual clinic with blood and imaging results, sending appointment reminders and scheduling follow up appointments. The responsibilities of patients randomized to the WATChmAN group will be to acknowledge these email/text appointment reminders (i.e. yes/no to being aware of upcoming appointments), checking their results virtually and scheduling follow-up appointments through the WATChmAN platform. The research coordinator and nurse will continue to oversee the WATChmAN function but will not be manually collating surveillance results (markers/imaging etc.). Patients randomized to the in-person AS group receive the traditional standard of care, returning to the clinic to meet with a physician face-to-face to receive their surveillance imaging and blood marker results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WATChmAN | Experimental | Other: WATChmAN Active SurveillancePatients 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. |
| Standard of Care | Active comparator | Other: In-person Active SurveillancePatients 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 may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WATChmAN Active SurveillanceWATChmAN 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. | Other | WATChmAN |
| In-person Active SurveillanceIn-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. | Other | Standard of Care |
Primary outcome
Safety and Efficacy
Time frame: December 2017 - December 2026
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.
3 secondary outcomes
Patient Satisfaction
Time frame: December 2017 - December 2026
Physician Satisfaction
Time frame: December 2017 - December 2026
Clinic Flow Metrics
Time frame: December 2017 - December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Hamilton, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATChmAN Active Surveillance and In-person Active Surveillance in people with Testicular Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy (time frame: December 2017 - December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.