Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients who have just been diagnosed with cancer.
These patients will be followed up with for one year.
结局指标
主要结局
The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer
时间窗: over a 12-month period
The primary objective of this longitudinal study is to diagnose insomnia and track its evolution and severity in patients newly diagnosed with cancer over the first year after diagnosis. Two validated questionnaires will be repeatedly administered: the Sleep Condition Indicator (SCI) and the Insomnia Severity Index (ISI). The SCI, based on DSM-5 criteria, identifies probable clinical insomnia by assessing symptom frequency, duration (difficulty falling asleep, night awakenings, early awakening), and functional impact. The ISI is a 7-item questionnaire evaluating perceived sleep difficulties over the past two weeks, including sleep initiation, maintenance, early awakening, daytime functioning, and distress. Total scores classify insomnia as absent, subclinical, moderate, or severe.
次要结局
- The secondary objective is to characterize the sleep quality in patients newly diagnosed with cancer.(over a 12-month period)
- The secondary objective is to characterize cancer-related pain in patients newly diagnosed with cancer.(over a 12-month period)
- The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer.(over 12-months period)
- The secondary objective is to characterize cancer-related quality of life in patients newly diagnosed with cancer.(over 12-months period)