Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 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)

Locations
Other Locations
Canada
University Health Network (Princess Margaret Hospital)
RECRUITING
Toronto
Contact Information
Primary
Denise Ng, MSc
denise.ng@uhn.ca
437-777-9562
Time Frame
Start Date: 2021-11-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Alberta Health services, Niagara Health System, Queen Elizabeth II Health Sciences Centre, Trillium Health Partners
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov