Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05033301

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nurse Ned Clinic

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT05033301

Start date

Nov 15, 2021

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Specialist-led Ned Clinic

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.

experimental: Nurse-led Ned Clinic

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.

Interventions

Nurse Ned Clinic

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.

Primary outcome measure

  • Changes in unmet needs [ Time Frame: Measured at Baseline, 6 months, 1 year ]

Central Contacts and Locations

Central contacts

Denise Ng, MSc

437-777-9562denise.ng@uhn.ca

Locations

University Health Network (Princess Margaret Hospital)

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Denise Ng

denise.ng@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • Digital Health
  • Nurse-led Care Model
  • Survivorship Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-07-11.