RecruitingRecruiting
Evaluating the Effectiveness of the Nurse Ned Clinic
NCT05033301 · University Health Network, Toronto
In plain English
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Official title
Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. 18 years of age or older
2. Completed curative-intent treatment
3. 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
4. Low risk of recurrence as determined by their treatment specialist
5. Adequate English ability (or a caregiver willing to provide translation) to complete study activities as determined by research assistant
6. Have an email address (or be able to use the email address of a caregiver)
Exclusion Criteria:
Patients with metastatic PCa are not eligible to participate in this research.
Study design
Enrollment target: 600 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-11-15
Estimated completion: 2026-12-30
Last updated: 2025-07-11
Interventions
Device: Nurse Ned Clinic
Primary outcomes
- • Changes in unmet needs (Measured at Baseline, 6 months, 1 year)
Sponsor
University Health Network, Toronto · other
With: Trillium Health Partners, Niagara Health System, Alberta Health services, Queen Elizabeth II Health Sciences Centre
Contacts & investigators
ContactDenise Ng, MSc · contact · denise.ng@uhn.ca · 437-777-9562
All locations (1)
University Health Network (Princess Margaret Hospital)Recruiting
Toronto, Ontario, Canada