Clinical trial NCT05033301: Evaluating the Effectiveness of the Nurse Ned Clinic
Official title: Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Digital Health
Nurse-led Care Model
Survivorship Care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Trillium Health Partners
name: Niagara Health System
name: Alberta Health services
name: Queen Elizabeth II Health Sciences Centre
First posted: 2021-09-02
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Changes in unmet needs
timeFrame: Measured at Baseline, 6 months, 1 year
Secondary outcomes:
measure: Changes to Participant's Health Status
timeFrame: Measured at Baseline, 6 months, 1 year
measure: Changes in Prostate Cancer health related quality of life
timeFrame: Measured at Baseline, 6 months, 1 year
measure: Changes in overall health related quality of life
timeFrame: Measured at Baseline, 6 months, 1 year
measure: Changes in Psychological Wellbeing
timeFrame: Measured at Baseline, 6 months, 1 year
measure: Changes in willingness to self-manage
timeFrame: Measured at Baseline and 1 year
measure: Changes to satisfaction with care
timeFrame: Measured at Baseline and 1 year
measure: Changes in health behaviours
timeFrame: Measured at Baseline and 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network (Princess Margaret Hospital)
state: Ontario
Study officials:
References: