Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and 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: Cognitive behavioral therapy for insomnia, Sleep education and skills.
- Кому может быть актуально
- Состояния в реестре: Cancer. Базовые параметры: 18 лет — 42 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors: Randomized Controlled Trial
Обзор
Young adult cancer survivors (YACS) commonly experience chronic insomnia due to many factors such as cancer related symptoms, effects of anti-cancer therapies, co-morbid mood disorders, and/or other psychosocial and economic stressors. Cognitive behavioral therapy for insomnia (CBT-I) is the gold standard for insomnia management but remains challenging to deliver to patients due to limited numbers of trained therapists, inconvenient scheduling availability, or prohibitive therapy costs. To address this critical gap in young adult cancer survivorship, the investigators propose to develop and test efficacy of the More Sleep Hours Electronic Education Program (More SHEEP), a novel system of smart speaker, smart lighting, and specialized Wi-Fi router that delivers AI-driven CBT-I to patients at home.
Подробное описание
Insomnia - defined as difficulty falling asleep, staying asleep, or nonrestorative sleep - is often accompanied by symptoms that impair daily function such as fatigue, difficulty concentrating, and mood disturbance. Affecting up to 75% of the estimated 650,000 young adult cancer survivors in the United States, insomnia has a myriad of psychological and medical sequelae that compound late in long-term effects of cancer diagnosis and treatment, including increased risk of mortality. Cognitive behavioral therapy for insomnia (CBT-I) remains the gold standard for managing chronic insomnia. Nevertheless, widespread access to trained CBT-I providers, even in accredited sleep centers, remains elusive: trained CBT-I therapists remain limited in number and traditional in-person CBT-I therapy can be time and cost prohibitive for patients. Newer attempts to develop automated web-based CBT-I are more didactic than interactive and can involve counterproductive use of smartphone screens at bedtime that can be activating and suppress the melatonin needed for sleep. To address this critical gap in young adult cancer survivorship care, the investigators propose the More Sleep Hours Electronic Education Program (More SHEEP): a CBT-I solution using a screen-free, conversational, AI-driven smart speaker, custom lighting to plan, remind and support YACS about the changes required to overcome insomnia, and a smart router to report on bedtime screen use. They propose a multi-phase project involving active patient stakeholder input and an iterative design process that will achieve the following Specific Aims: Aim 1) maximize feasibility, usability, and acceptability of the interactive CBT-I prototype; Aim 2) finalize the prototype and conduct pilot field testing of the intervention for usability; Aim 3) conduct a randomized controlled trial to determine the impact of these integrated CBT-I components on insomnia symptoms among young adult cancer survivors compared to an attention control. Successful completion of these Aims will further their long-term goal of providing novel, affordable, available, scalable, evidence-driven solutions for moderate-severe chronic insomnia among young adult cancer survivors. Furthermore, this technology can eventually be translated to other patient populations living with cancer or other serious illnesses.
Вмешательства
- Поведенческое Cognitive behavioral therapy for insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment that helps people change thoughts and behaviors that interfere with sleep, using techniques like stimulus control, sleep restriction, cognitive restructuring, and relaxation training. - Поведенческое Sleep education and skills
Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep
Первичные конечные точки
- Insomnia Severity Index [Срок оценки: Baseline (Day 0) and Post Intervention (6 Weeks)]
Вторичные конечные точки (5)
- Functional Assessment of Cancer Therapy - General [Срок оценки: Baseline (Day 0) and Post Intervention (6 Weeks)]
- Functional Assessment of Cancer Therapy - Cognitive Function [Срок оценки: Baseline (Day 0) and Post Intervention (6 Weeks)]
- Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire) [Срок оценки: Post Intervention (6 Weeks)]
- Recommendation of Assigned Intervention to Family/Friends [Срок оценки: Post Intervention (6 Weeks)]
- System Usability Scale [Срок оценки: Post Intervention (6 Weeks)]
Критерии участия
Критерии включения
- Age 18-42 at time of enrollment
- history of cancer diagnosis (any type) diagnosed at/after age 15, received all treatment before age 40
- at least 6 months from date of cancer diagnosis
- history of chronic sleep disorder with Insomnia Severity Index >/= 8
Критерии исключения
- Refusal to try the study intervention
- diagnosed untreated obstructive sleep apnea syndrome, or restless leg syndrome
- narcolepsy, schizophrenia, bi-polar disorder, and/or poorly controlled psychiatric diagnoses
- disease-related prognosis of less than 6 months or currently enrolled in hospice care
- planned travel out of the continental United States during the study period.
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
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07318545 · STUDY00009801 · 2R44CA254637-02