Prostate CancerNurseNedNCT05033301
Evaluating the Effectiveness of the Nurse Ned Clinic
A study testing Nurse Ned Clinic in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) survivors. Through this trial, investigators will compare pre-determined survivorship outcomes of men receiving care via traditional specialist-led PCa virtual care… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Nurse Ned Clinic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2021to 30 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
- 18 years of age or older
- Completed curative-intent treatment
- Receiving PCa survivorship care at University Health Network (UHN), Trillium Health Partners (THP), Niagara Health System (NHS), Prostate Cancer Centre - Calgary (PCCC), or Queen Elizabeth II Health Sciences Centre (QEII HSC)-affiliated hospital
- Low risk of recurrence as determined by their treatment specialist
- Adequate English ability (or a caregiver willing to provide translation) to complete study activities as determined by research assistant
- Have an email address (or be able to use the email address of a caregiver)
Who cannot join
- Patients with metastatic PCa are not eligible to participate in this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, M5G 2C4
Denise Ng, denise.ng@uhn.ca
About this study
Official title: Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) survivors. Through this trial, investigators will compare pre-determined survivorship outcomes of men receiving care via traditional specialist-led PCa virtual care model (Specialist Ned) to those receiving care via the newly-proposed nurse-led PCa virtual care model (Nurse Ned). In total, it is anticipated that a maximum of 600 men (300 in control arm; 300 in intervention arm) across five clinical sites (3 in Ontario; 1 in Alberta; and 1 in Nova Scotia) will be enrolled into this trial and will be followed for 12 months.
Read the detailed description
Prostate cancer (PCa) is the most common cancer among Canadian men, with over 25,000 diagnosed yearly. While advances in treatment and care, including the PSA (prostate-specific antigen) test have resulted in more men entering survivorship and living longer, many continue to experience undesirable symptoms, side effects and psychosocial concerns. The current healthcare system is not optimized to deliver survivorship care at scale and struggles to support the increasing number of survivors across the cancer care continuum. Increasing patient loads in specialty clinics result in brief and infrequent follow-up visits, leaving patients without the opportunity to ask questions and fully understand their health status, all the while tasking providers with making quick and effective treatment decisions with minimal patient information or interaction.
In order to address this increasing need for improved care delivery, investigators have developed the Ned ("No Evidence of Disease") PCa survivorship platform, which allows patients to access clinical information (i.e. lab results), virtually complete patient reported outcomes (PROs) on their quality of life, and complete virtual visits with their specialist. Despite the promise and potential of Ned, ongoing evaluation of this platform shows specialists often lacked the availability and flexibility to consistently review ePROs and lab results prior to a study visit. In response, researchers aim to expand the current Ned platform to design, develop and implement a digitally mediated nurse-led survivorship care model that can address the growing needs of prostate cancer survivors and healthcare providers at scale.
In this trial, investigators aim to evaluate the effectiveness of a nurse-led survivorship care model by comparing the clinical outcomes of patients enrolled in the Specialist Ned Clinic (control) for their PCa follow-up care and those that will be enrolled into the Nurse Ned Clinic (intervention) a year later. Participants will be enrolled in the study for one year, and will be asked to complete standardized questionnaires related to their PCa follow-up care at the start of the study, 6-months into using their respective Ned Clinic and at study completion.
- Conditions
- Prostate Cancer
- Being tested
- Nurse Ned Clinic
- Keywords
- Digital Health, Nurse-led Care Model, Survivorship Care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Ned ClinicDevice
Participants enrolled in the Nurse-led Ned Clinic will receive virtual PCa survivorship follow-up care from both their specialist and an oncology nurse for one year.
| Study group | Role | What they receive |
|---|---|---|
| Specialist-led Ned Clinic | No intervention | Participants enrolled in specialist-led version of the Ned Virtual Clinic will be prompted to complete their PROs (EPIC-26 survey) and PSA/testosterone lab tests in accordance to their pre-specified follow-up surveillance protocol determined by the specialist for one year. |
| Nurse-led Ned Clinic | Experimental | Participants enrolled in the nurse-led version of the Ned Virtual Clinic will be prompted to complete their PROs (EPIC-26 survey) and PSA/testosterone lab tests in accordance to their pre-specified follow-up surveillance protocol determined by the specialist. In addition, men will be asked to complete another set of PROs that will be monitored by a trained oncology nurse, in between their specialist visits. Receives: Device: Nurse Ned Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in unmet needs
Assessed by Cancer Survivors' Unmet Needs (CaSUN) questionnaire. The questionnaire is a 42-item instrument that captures the current needs of a cancer survivor, such as medical care, quality of life, emotional and relationship needs and their current view of life.
Measured: Measured at Baseline, 6 months, 1 year
Secondary outcomes (7)
Changes to Participant's Health Status
Assessed by the EQ5D-5L questionnaire. This questionnaire contains 6 questions which assess the patient's health status by understanding how they feel about their mobility, self-care, usual activities, pain/discomfort and levels of anxiety or depression.
Measured: Measured at Baseline, 6 months, 1 year
Changes in Prostate Cancer health related quality of life
Assessed by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The questionnaire is a 13-item instrument that captures the side effects and symptoms that might affect the quality of life in patients with prostate cancer patients.
Measured: Measured at Baseline, 6 months, 1 year
Changes in overall health related quality of life
Assessed by the Functional Assessment of Cancer Therapy for Prostate Cancer patients (FACT-P). This questionnaire is a 39-item instrument that assesses the quality of health-related well-being for patients with prostate cancer.
Measured: Measured at Baseline, 6 months, 1 year
Changes in Psychological Wellbeing
Assessed by the General Health Questionnaire (GHQ-12). This questionnaire contains 12-questions that ask prostate cancer patients how they have been feeling in the past weeks.
Measured: Measured at Baseline, 6 months, 1 year
Changes in willingness to self-manage
Assessed by the Patient Activation Measure Questionnaire (PAM-13). This questionnaire is a 13-item instrument that quantifies a patient's readiness to engage in their own self-management.
Measured: Measured at Baseline and 1 year
Changes to satisfaction with care
Assessed by the Care Satisfaction Questionnaire. This questionnaire is an 11-item instrument used to quantify experience and acceptability of follow-up care.
Measured: Measured at Baseline and 1 year
Changes in health behaviours
Assessed by the Health Behaviour Questionnaire. This questionnaire is used to determine participant health practices (e.g. smoking, fitness, alcohol consumption).
Measured: Measured at Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start15 Nov 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Trillium Health Partners, Niagara Health System, Alberta Health services, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033301
- Sponsor's protocol ID
- 21-5188
- Acronym
- NurseNed
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Findings from the study will be published and shared through open-accessed peer review journals and scientific conferences within the digital health and cancer respective fields. Results will be shared in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
- ClinicalTrials.gov ID
- NCT05033301
- Acronym / sponsor ID
- NurseNed / 21-5188
- Conditions
- Prostate Cancer
- Keywords
- Digital Health, Nurse-led Care Model, Survivorship Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Trillium Health Partners, Niagara Health System, Alberta Health services, Queen Elizabeth II Health Sciences Centre
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Sep 2021 (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.
The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) survivors. Through this trial, investigators will compare pre-determined survivorship outcomes of men receiving care via traditional specialist-led PCa virtual care model (Specialist Ned) to those receiving care via the newly-proposed nurse-led PCa virtual care model (Nurse Ned). In total, it is anticipated that a maximum of 600 men (300 in control arm; 300 in intervention arm) across five clinical sites (3 in Ontario; 1 in Alberta; and 1 in Nova Scotia) will be enrolled into this trial and will be followed for 12 months.
Detailed description
Prostate cancer (PCa) is the most common cancer among Canadian men, with over 25,000 diagnosed yearly. While advances in treatment and care, including the PSA (prostate-specific antigen) test have resulted in more men entering survivorship and living longer, many continue to experience undesirable symptoms, side effects and psychosocial concerns. The current healthcare system is not optimized to deliver survivorship care at scale and struggles to support the increasing number of survivors across the cancer care continuum. Increasing patient loads in specialty clinics result in brief and infrequent follow-up visits, leaving patients without the opportunity to ask questions and fully understand their health status, all the while tasking providers with making quick and effective treatment decisions with minimal patient information or interaction.
In order to address this increasing need for improved care delivery, investigators have developed the Ned ("No Evidence of Disease") PCa survivorship platform, which allows patients to access clinical information (i.e. lab results), virtually complete patient reported outcomes (PROs) on their quality of life, and complete virtual visits with their specialist. Despite the promise and potential of Ned, ongoing evaluation of this platform shows specialists often lacked the availability and flexibility to consistently review ePROs and lab results prior to a study visit. In response, researchers aim to expand the current Ned platform to design, develop and implement a digitally mediated nurse-led survivorship care model that can address the growing needs of prostate cancer survivors and healthcare providers at scale.
In this trial, investigators aim to evaluate the effectiveness of a nurse-led survivorship care model by comparing the clinical outcomes of patients enrolled in the Specialist Ned Clinic (control) for their PCa follow-up care and those that will be enrolled into the Nurse Ned Clinic (intervention) a year later. Participants will be enrolled in the study for one year, and will be asked to complete standardized questionnaires related to their PCa follow-up care at the start of the study, 6-months into using their respective Ned Clinic and at study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialist-led Ned Clinic | No intervention | –Participants enrolled in specialist-led version of the Ned Virtual Clinic will be prompted to complete their PROs (EPIC-26 survey) and PSA/testosterone lab tests in accordance to their pre-specified follow-up surveillance protocol determined by the specialist for one year. |
| Nurse-led Ned Clinic | Experimental | Device: Nurse Ned ClinicParticipants enrolled in the nurse-led version of the Ned Virtual Clinic will be prompted to complete their PROs (EPIC-26 survey) and PSA/testosterone lab tests in accordance to their pre-specified follow-up surveillance protocol determined by the specialist. In addition, men will be asked to complete another set of PROs that will be monitored by a trained oncology nurse, in between their specialist visits. |
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)
- 18 years of age or older
- Completed curative-intent treatment
- Receiving PCa survivorship care at University Health Network (UHN), Trillium Health Partners (THP), Niagara Health System (NHS), Prostate Cancer Centre - Calgary (PCCC), or Queen Elizabeth II Health Sciences Centre (QEII HSC)-affiliated hospital
- Low risk of recurrence as determined by their treatment specialist
- Adequate English ability (or a caregiver willing to provide translation) to complete study activities as determined by research assistant
Key exclusion criteria (1 listed)
- Patients with metastatic PCa are not eligible to participate in this research.
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 |
|---|---|---|
| Nurse Ned ClinicParticipants enrolled in the Nurse-led Ned Clinic will receive virtual PCa survivorship follow-up care from both their specialist and an oncology nurse for one year. | Device | Nurse-led Ned Clinic |
Primary outcome
Changes in unmet needs
Time frame: Measured at Baseline, 6 months, 1 year
Assessed by Cancer Survivors' Unmet Needs (CaSUN) questionnaire. The questionnaire is a 42-item instrument that captures the current needs of a cancer survivor, such as medical care, quality of life, emotional and relationship needs and their current view of life.
7 secondary outcomes
Changes to Participant's Health Status
Time frame: Measured at Baseline, 6 months, 1 year
Changes in Prostate Cancer health related quality of life
Time frame: Measured at Baseline, 6 months, 1 year
Changes in overall health related quality of life
Time frame: Measured at Baseline, 6 months, 1 year
Changes in Psychological Wellbeing
Time frame: Measured at Baseline, 6 months, 1 year
Changes in willingness to self-manage
Time frame: Measured at Baseline and 1 year
Changes to satisfaction with care
Time frame: Measured at Baseline and 1 year
Changes in health behaviours
Time frame: Measured at Baseline and 1 year
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 11 Jul 2025.
- Individual participant dataSharing planned: No. Findings from the study will be published and shared through open-accessed peer review journals and scientific conferences within the digital health and cancer respective fields. Results will be shared in aggregate.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Ned Clinic in people with Prostate 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 1 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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?
Contact Denise Ng, MSc (437-777-9562, denise.ng@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in unmet needs (time frame: Measured at Baseline, 6 months, 1 year). 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 11 Jul 2025.