Идёт набор NCT06813235

Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

Без фазы С лечением Neoplasm Sleep Disturbance

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: iDream2Heal, Easy Exercise, Dream2Heal, iDream2Heal & Easy Exercise.
Кому может быть актуально: Состояния в реестре: Neoplasm, Sleep Disturbance. 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: Гонконг
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

Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

Обзор

Подробное описание

The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design. First, the investigators will test the effect of a low intensity web-based cognitive behavioural therapy for insomnia (CBT-I) intervention (iDream2Heal; iD2H), in comparison to a low intensity web-based exercise intervention (Easy Exercise; eEX). Secondly, this study aims to explore if a stepped-up face to face, therapist led CBT-I intervention (D2H) is more effective for patients who continue to have sleep disturbance, in comparison to an augmented intervention, in which is a combined, web-based intervention that covers the content of both iD2H and eEX interventions.

Вмешательства

Поведенческое iDream2Heal
iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
Поведенческое Easy Exercise
Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
Поведенческое Dream2Heal
Dream2Heal (D2H) is a manualised, multi-component intervention which is grounded with core CBT-I elements of stimulus control, sleep restriction, sleep hygiene, relaxation training, and cognitive restructuring.
Поведенческое iDream2Heal & Easy Exercise
The augmented iDream2Heal \& Easy Exercise (iD2H \& eEX) intervention is a combined, unsupervised, self-guided web-based intervention that covers the content of iD2H and eEX interventions.

Первичные конечные точки

Feasibility outcome (1.1) [Срок оценки: baseline (T0)]
Feasibility outcome (1.2) [Срок оценки: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)]
Feasibility outcome (1.3) [Срок оценки: post-intervention (T1) and 4-month post-intervention (T2)]
Feasibility outcome (2) [Срок оценки: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)]
Sleep disturbance [Срок оценки: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).]

Вторичные конечные точки (2)

Hospital Anxiety and Depression Scale (HADS) [Срок оценки: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).]
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) [Срок оценки: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).]

Критерии участия

Критерии включения

Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer
Completed treatment (except endocrine therapy) within two years
Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance