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Идёт набор NCT05033301

Evaluating the Effectiveness of the Nurse Ned Clinic

Без фазы С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nurse Ned Clinic.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Changes in unmet needs [Срок оценки: Measured at Baseline, 6 months, 1 year]
Вторичные конечные точки (7)
  • Changes to Participant's Health Status [Срок оценки: Measured at Baseline, 6 months, 1 year]
  • Changes in Prostate Cancer health related quality of life [Срок оценки: Measured at Baseline, 6 months, 1 year]
  • Changes in overall health related quality of life [Срок оценки: Measured at Baseline, 6 months, 1 year]
  • Changes in Psychological Wellbeing [Срок оценки: Measured at Baseline, 6 months, 1 year]
  • Changes in willingness to self-manage [Срок оценки: Measured at Baseline and 1 year]
  • Changes to satisfaction with care [Срок оценки: Measured at Baseline and 1 year]
  • Changes in health behaviours [Срок оценки: Measured at Baseline and 1 year]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • University Health Network (Princess Margaret Hospital) — Toronto

Идентификаторы

NCT: NCT05033301 · 21-5188

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗