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Идёт набор NCT07162987

Prehabilitation to Patients With Prostate Cancer

Без фазы С лечением Prostate Cancer (Diagnosis)

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: Prehabilitation.
Кому может быть актуально
Состояния в реестре: Prostate Cancer (Diagnosis). 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy

Обзор

The goal of this feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. The main questions it aims to answer are: * Are patients and their close relatives willing to take part in prehabilitation? * What is the acceptability and feasibility of the prehabilitation intervention, seen from the perspectives of patients, their close relatives, and healthcare professionals? * Are the planned data collection methods feasible, and are there indications of a clinical effect? Participants will: * Take part in 12 weeks of physical exercise training * Attend a 4-day residential prehabilitation intervention, where they receive education and do exercises. After 12 weeks, it is possible to take part in a voluntary follow-up session. * Patients will respond to questionnaires about their health, symptoms, and quality of life. Patients and their close relatives will attend a group interview. Patients will also complete an exercise diary and brief physical tests

Вмешательства

  • Поведенческое Prehabilitation
    Please refer to arm description

Первичные конечные точки

  • Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30 [Срок оценки: From baseline (shortly after enrollment) to 24 and 48 weeks later.]
Вторичные конечные точки (7)
  • Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26 [Срок оценки: Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.]
  • Change in fatigue from baseline to follow-up using the BFI [Срок оценки: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks.]
  • Change in anxiety from baseline to follow up measured by the GAD-7 [Срок оценки: At baseline (shortly after inclusion) and at 24 and 48 weeks.]
  • Change in depression from baseline to follow-up measured by the PHQ-9 [Срок оценки: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks]
  • Change in BMI from baseline to follow-up calculated from self-reported height and weight [Срок оценки: Baseline and at 24 and 48 weeks.]
  • Change in muscle strength from baseline to follow-up measured by 30 sec sit-to-stand test [Срок оценки: Baseline and after finished exercise training at 12 weeks]
  • Change in function from baseline to follow-up measured by the 6MWT [Срок оценки: Baseline and after finished exercise training at 12 weeks]

Критерии участия

Критерии включения

  • Diagnosed with prostate cancer
  • min 18 years old
  • Treatment: Androgen deprivation therapy and raditation therapy
  • Resident in Vejle Municipality or Esbjerg Municipality
  • Can take part in residential prehabiliation in week 43 or 50, 2025, as well as physical exsercise training in the municipality
  • Willing to take part in a research study
  • Suited to take part in group sessions
  • Be able to read and be understood in Danish
  • Be responsible for own personal hygiene and medications at the 4-day residential stay

Критерии исключения

  • Persons who do not fulfil the inclusion criteria will be excluded

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Дания · 3 центра
  • Esbjerg Hospital — Esbjerg
  • REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care — Nyborg
  • Vejle Hospital — Vejle

Идентификаторы

NCT: NCT07162987 · 25/31257

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗