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Идёт набор NCT07692763

Evaluating the YATAC Programme

Без фазы С лечением Cancer Young Adults

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: YATAC programme, Standard rehabilitation.
Кому может быть актуально
Состояния в реестре: Cancer, Young Adults. Базовые параметры: 18 лет — 39 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
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

The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults

Обзор

Young adults aged 18-39 years with cancer often experience physical, psychological, and social challenges that affect their participation in everyday life and their health-related quality of life. Existing cancer rehabilitation services are rarely tailored to the specific needs of this age group. The Young Adults Taking Action (YATAC) programme was developed together with young adults with cancer, healthcare professionals, and researchers to provide age-specific rehabilitation that supports young adults in managing cancer-related challenges and returning to everyday life. The aim of this pilot randomized controlled trial is to evaluate the feasibility of conducting a larger trial of the YATAC programme in a municipal rehabilitation setting. The study will examine recruitment, retention, acceptability of randomization, data completeness, assessment burden, and adverse events. In addition, the study will provide preliminary estimates of the programme's effects on health-related quality of life and self-efficacy. Fifty young adults aged 18-39 years who are undergoing or have completed curative-intent treatment will be recruited through municipal cancer rehabilitation services in Aarhus Municipality, Denmark. Participants will be randomly assigned to receive either the 16-week YATAC programme or usual cancer rehabilitation services. The YATAC programme includes an individual needs assessment and goal setting, followed by group-based and individual sessions addressing physical activity, fatigue, sleep and cognitive challenges, mental health, sexuality and relationships, family and friends, nutrition, and education or work. Outcomes will be assessed at baseline and at 4, 6, and 12 months after enrolment.

Подробное описание

Details will be included a protocol paper which will be submitted to an open-access journal.

Вмешательства

  • Поведенческое YATAC programme
    The YATAC 2.0 intervention will consist of a 16-week multidimensional rehabilitation programme including a mandatory needs assessment and goal-setting component, which will determine the primarily group-based components in which the young adults will participate. These components will include: 1) Physical activity, 2) Fatigue, sleep, and cognitive challenges, 3) Mental health, 4) Sexuality and relationships, 5) Family and friends, 6) Nutrition, and 7) Education and work. Each participant will b
  • Поведенческое Standard rehabilitation
    Participants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise.

Первичные конечные точки

  • Recruitment rate [Срок оценки: Baseline]
  • Acceptability of randomisation [Срок оценки: Baseline]
  • Attrition rate [Срок оценки: Up to 12 months after baseline]
  • Adverse events [Срок оценки: Four months after baseline]
  • Completeness of data [Срок оценки: Four months after baseline]
  • Assessment burden [Срок оценки: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
Вторичные конечные точки (3)
  • Health-related quality of life [Срок оценки: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
  • AYA-specific quality of life [Срок оценки: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
  • Self-Efficacy [Срок оценки: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]

Критерии участия

Критерии включения

  • Between 18 and 39 years of age
  • Are currently undergoing or have completed curative-intent cancer treatment within the past five years
  • Can understand and communicate in Danish and provide informed consent independently
  • Have been referred to municipal cancer rehabilitation services in the Municipality of Aarhus

Критерии исключения

  • Diagnosed with cancer before the age of 18
  • Previously or currently receive rehabilitation

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Дания · 1 центр
  • Folkesundhed (Public Health), the Municipality of Aarhus — Aarhus

Идентификаторы

NCT: NCT07692763 · Young Adult Taking ACtion · R379-A22563 · 23-20-0478 · R95-A4572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗