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Набор скоро начнётся NCT06845267

Chrono-behavioral Therapy for Chronic Fatigue in Cancer

Без фазы С лечением Chronic Fatigue Cancer Survivors

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: Chronotherapy, Control.
Кому может быть актуально
Состояния в реестре: Chronic Fatigue, Cancer Survivors. Базовые параметры: от 18 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
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Обзор

Cancer-related fatigue (CRF) is a severe and persistent side effect of cancer and its treatment, affecting up to 40% of patients and significantly reducing quality of life. Recent research suggests that circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are 24-hour cycles regulating physiology and behavior through environmental cues called "zeitgebers." Strengthening these cues-such as light exposure, physical activity, and eating-may help reduce CRF. This project will develop and test the optimal combination a home-based, low-burden chrono-behavioral therapy (ChronoBT) targeting these zeitgebers.

Подробное описание

Cancer-related fatigue (CRF) is frequently reported as the most severe and distressing side effect of cancer and its treatment. Among cancer patients, up to 40% will experience CRF that can last months or even years after treatment and it is also deleterious to quality of life. However, there is still no established CRF treatment. Underlying mechanisms of CRF are likely multi-factorial and recently, circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are endogenous 24-hour cycles of rhythmicity in physiology and behavior orchestrated by the suprachiasmatic nuclei (SCN) in the brain. They are entrained to the environment via time-giving cues called "zeitgebers". Thus, improving circadian rhythm robustness by strengthening modifiable zeitgebers is one potential way to ameliorate CRF. The overarching goal of the proposed project is to conduct an optimization trial of a home-based, low-burden multicomponent chrono-behavioral therapy (ChronoBT) that aims to strengthen the effects of 3 zeitgebers to treat CRF - light/dark exposure, physical activity and eating - all of which individually have shown promise in strengthening circadian rhythms and reducing fatigue. The study will include two work packages: In Work Package 1 (WP1), the investigators will pilot test candidate intervention components in prostate and female breast cancer survivors. In Work Package 2 (WP2), a fully powered optimization trial will be undertaken using the framework - the Multiphase Optimization Strategy (MOST), to test the optimal combination of ChronoBT components.

Вмешательства

  • Поведенческое Chronotherapy
    This study utilize and test different combinations of three types of interventions (zeitgebers) to entrain the circadian rhythm: 1) Light being the primary photic zeitgebers that directly entrain the SCN, 2) physical activity and 3) timing of eating) being non-photic zeitgebers that drive peripheral rhythms.
  • Поведенческое Control
    Control condition

Первичные конечные точки

  • Cancer-related Fatigue [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
Вторичные конечные точки (9)
  • Sleep Quality [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
  • Insomnia [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
  • Anxiety and Depression [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
  • Health-related Quality of Life [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
  • Cognition [Срок оценки: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]
  • Circadian Function [Срок оценки: During the entire period of intervention and follow-up T4 (4 weeks post intervention completion)]
  • Chronotype [Срок оценки: T1 (Baseline)]
  • Credibility/Expectancy [Срок оценки: T1 (Baseline)]
  • Treatment Satisfaction [Срок оценки: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)]

Критерии участия

Критерии включения

  • prostate or female breast cancer survivors
  • completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously
  • ≥18 years of age
  • able to speak and read Danish
  • experiencing CRF (score ≤36 on FACT-F)

Критерии исключения

  • use of light therapy in the last year
  • confounding underlying medical/psychiatric disorders or use of medications associated with fatigue (e.g., a central nervous system cancer, untreated hypothyroidism, anemia, chronic fatigue syndrome, insomnia, major depression)
  • non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)
  • recurrence of cancer or new cancer
  • physical or psychological conditions that could prevent participation in intervention components
  • use of photosensitizing medications

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
Лечение

Центры проведения

Дания · 1 центр
  • Aarhus University and Aarhus University Hospital — Aarhus

Идентификаторы

NCT: NCT06845267 · ChronoBT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗