Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cancer, Insomnia, Pain, Depression Anxiety Disorder. Базовые параметры: 18 лет — 80 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
- Франция
- 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
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
Обзор
The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time. A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties. The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.
Первичные конечные точки
- The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer [Срок оценки: over a 12-month period]
Вторичные конечные точки (4)
- The secondary objective is to characterize the sleep quality in patients newly diagnosed with cancer. [Срок оценки: over a 12-month period]
- The secondary objective is to characterize cancer-related pain in patients newly diagnosed with cancer. [Срок оценки: over a 12-month period]
- The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer. [Срок оценки: over 12-months period]
- The secondary objective is to characterize cancer-related quality of life in patients newly diagnosed with cancer. [Срок оценки: over 12-months period]
Критерии участия
Критерии включения
- Confirmed diagnosis of metastatic or non-metastatic cancer,
- Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously,
- Age ≥ 18 years,
- Ability to read and understand French,
- Patient covered by a social security system,
- Signed informed consent.
Критерии исключения
- SCI questionnaire score <16
- Diagnosed or controlled sleep disorders
- Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient
- Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- 12 boulevard du Dr Chantemesse — Le Puy-en-Velay
Идентификаторы
NCT: NCT07280416 · RIPH2_PANTE_INDICA · ID-RCB