Virtual Nurse-Led Clinic for Prostate Cancer

(NurseNed Trial)

Overseen By Denise Ng, MSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastatic prostate cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a virtual nurse-led clinic, called the Nurse Ned Clinic, for men who have completed prostate cancer treatment. It compares two groups: those receiving virtual care from a nurse and those receiving it from a specialist. The trial focuses on determining which approach better supports men after their initial treatment. Men who have finished prostate cancer treatment and are at low risk of recurrence may be suitable for this study. Participants must be able to complete study activities in English and have access to email. As an unphased trial, this study allows participants to contribute to innovative care approaches that could enhance post-treatment support for others.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this virtual nurse-led clinic is safe for prostate cancer survivors?

Research shows that the Nurse Ned Clinic, a virtual program led by nurses for prostate cancer survivors, receives positive feedback from patients. Studies have reported that both healthcare professionals and patients experience virtual care as easy and convenient. Reviews of similar nurse-led virtual clinics indicate they help patients manage their health without major side effects. Although this trial doesn't focus on specific side effects, existing evidence suggests that patients generally find the treatment safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Nurse-Led Clinic for prostate cancer because it offers a personalized and proactive approach to patient care. Unlike traditional methods, where patients primarily rely on specialist visits, this clinic empowers trained oncology nurses to actively monitor patients by prompting them to complete surveys and lab tests. This approach could enhance patient engagement and potentially lead to earlier detection of changes in their condition. Additionally, it provides continuous support between specialist visits, which might improve patient outcomes and overall satisfaction.

What evidence suggests that this trial's treatments could be effective for prostate cancer survivors?

This trial will compare a nurse-led virtual clinic with a specialist-led virtual clinic for prostate cancer care. Research has shown that nurse-led virtual clinics can be an effective option for prostate cancer care. Studies indicate that patients in these clinics often benefit from quick decision-making and regular follow-ups, enhancing their overall experience and safety. These clinics use electronic tools to monitor patient health between specialist visits. This approach has been linked to better management of side effects and higher patient satisfaction. Overall, early evidence suggests that a nurse-led virtual clinic can effectively support prostate cancer survivors in their ongoing care. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for men over 18 who've finished treatment for prostate cancer and are at low risk of recurrence. They must be getting care at certain Canadian hospitals, speak English (or have a translator), and have an email address.

Inclusion Criteria

My doctor considers my cancer at low risk of coming back.

I have access to an email address.

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

Exclusion Criteria

I do not have prostate cancer that has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants complete standardized questionnaires related to their PCa follow-up care at the start of the study

1 week

1 visit (virtual)

Intervention

Participants receive care via either the Specialist Ned or Nurse Ned virtual clinic models, completing PROs and lab tests as per protocol

12 months

Regular virtual visits

Follow-up

Participants are monitored for changes in health status, quality of life, and satisfaction with care

12 months

3 assessments (Baseline, 6 months, 1 year)

What Are the Treatments Tested in This Trial?

Interventions

• Nurse Ned Clinic

Trial Overview The study compares traditional specialist-led virtual care with a new nurse-led virtual clinic for prostate cancer survivors. It's not random; patients choose their group, aiming to enroll 600 men across five sites in Canada.

How Is the Trial Designed?

Group I: Nurse-led Ned Clinic Experimental Treatment 1 Intervention

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.

Group II: Specialist-led Ned Clinic Active Control 1 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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Trillium Health Partners

Collaborator

Trials

8

Recruited

3,100+

Niagara Health System

Collaborator

Trials

9

Recruited

2,800+

Rockyview General Hospital

Collaborator

Trials

3

Recruited

4,200+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05033301?lupd_s=08%2F29%2F2021

Evaluating the Effectiveness of the Nurse Ned Clinic The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10622495/

A qualitative study on healthcare professional and patient ... A qualitative descriptive study exploring follow-up and virtual care experiences to inform a nurse-led virtual clinic (Ned Nurse) with an a priori convenience ...

3. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-024-02669-x

A digital and nurse-led support intervention, first year after ... This study aims to test the feasibility of a complex intervention that includes electronic patient-reported outcomes and self-management advice ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/11/4/e045806

Virtual care for prostate cancer survivorship Effectiveness outcome measures. This evaluation aims to compare the nurse-led Ned Clinic with specialist-led follow-up care across a series of outcomes that ...

5. cancer.jmir.org cancer.jmir.org/2023/1/e44332/

An Actionable Expert-System Algorithm to Support Nurse-Led ... The algorithm is called No Evidence of Disease (Ned) and supports timelier decision-making, enhanced safety, and continuity of care. Methods: An ...