跳至主要内容
临床试验/NCT05033301
NCT05033301招募中不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Changes in unmet needs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • Patients with metastatic PCa are not eligible to participate in this research.

结局指标

主要结局

Changes in unmet needs

时间窗: Measured at Baseline, 6 months, 1 year

Assessed by Cancer Survivors' Unmet Needs (CaSUN) questionnaire. The questionnaire is a 42-item instrument that captures the current needs of a cancer survivor, such as medical care, quality of life, emotional and relationship needs and their current view of life.

次要结局

  • Changes in Psychological Wellbeing(Measured at Baseline, 6 months, 1 year)
  • Changes in Prostate Cancer health related quality of life(Measured at Baseline, 6 months, 1 year)
  • Changes in overall health related quality of life(Measured at Baseline, 6 months, 1 year)
  • Changes in willingness to self-manage(Measured at Baseline and 1 year)
  • Changes to Participant's Health Status(Measured at Baseline, 6 months, 1 year)
  • Changes to satisfaction with care(Measured at Baseline and 1 year)
  • Changes in health behaviours(Measured at Baseline and 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验