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Идёт набор NCT05790850

Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

Без фазы С лечением Bladder Cancer Non-muscle-invasive Bladder Cancer Muscle-Invasive Bladder Carcinoma

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: Pre-operative physical exercise, Pre-operative mindfulness meditation practice.
Кому может быть актуально
Состояния в реестре: Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.

Вмешательства

  • Поведенческое Pre-operative physical exercise
    Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.
  • Поведенческое Pre-operative mindfulness meditation practice
    Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.

Первичные конечные точки

  • Number of patient-reported days devoted to solitary psychological support [Срок оценки: 30 days]
  • Number of patient-reported days devoted to exercise [Срок оценки: 30 days]
Вторичные конечные точки (5)
  • Post-operative complication rate [Срок оценки: 30 days post-operatively]
  • Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire. [Срок оценки: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET) [Срок оценки: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS) [Срок оценки: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10) [Срок оценки: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]

Критерии участия

Критерии включения

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥18 years of age
  • Good surgical candidate determined by treating surgeon
  • Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology
  • Adequate Organ Function per protocol definition
  • ECOG performance status ≤2
  • Received medical clearance to complete cardiopulmonary exercise testing
  • Willing to use the personal or study provided devices for monitoring and performing the exercise routines.
  • Fluent in English or Spanish for the EORTC QLQ questionnaire
  • No known contraindications to high intensity exercise

Критерии исключения

  • Contraindications to participating in aerobic exercise
  • Currently participating in an aerobic exercise program
  • New onset chest pain nor dyspnea with exertion
  • Histologically documented micropapillary or sarcomatoid bladder cancer
  • Distant metastatic carcinoma

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Virginia — Charlottesville

Идентификаторы

NCT: NCT05790850 · HSR210502

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗