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Spots Global Cancer Trial Database for Evaluating the Effectiveness of the Nurse Ned Clinic

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Trial Identification

Brief Title: 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 ID: NCT05033301

Conditions

Prostate Cancer

Interventions

Nurse Ned Clinic

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

University Health Network (Princess Margaret Hospital), Toronto, Ontario, Canada

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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