Evaluating the Effectiveness of the Nurse Ned Clinic
NurseNed
Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
1 other identifier
interventional
600
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Nov 2021
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
July 11, 2025
July 1, 2025
5.1 years
August 21, 2021
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 at Baseline, 6 months, 1 year
Secondary Outcomes (7)
Changes to Participant's Health Status
Measured at Baseline, 6 months, 1 year
Changes in Prostate Cancer health related quality of life
Measured at Baseline, 6 months, 1 year
Changes in overall health related quality of life
Measured at Baseline, 6 months, 1 year
Changes in Psychological Wellbeing
Measured at Baseline, 6 months, 1 year
Changes in willingness to self-manage
Measured at Baseline and 1 year
- +2 more secondary outcomes
Study Arms (2)
Specialist-led Ned Clinic
NO INTERVENTIONParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients with metastatic PCa are not eligible to participate in this research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Trillium Health Partnerscollaborator
- Niagara Health Systemcollaborator
- Alberta Health servicescollaborator
- Queen Elizabeth II Health Sciences Centrecollaborator
Study Sites (1)
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2021
First Posted
September 2, 2021
Study Start
November 15, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
July 11, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
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.