Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery: A Multicenter, Observational, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Change from baseline in Restless Legs Syndrome questionnaire scores
研究概览
简要总结
The main aim of this study is to prospectively evaluate the occurrence of sleep disorders in patients undergoing thoracic surgery due to the preliminary diagnosis of lung cancer. Secondary aims include anxiety, depressive mood and functional outcomes before and 3 months after the intervention.
详细描述
Cancer surgery is one of the traumas that affect human life, starting from diagnostic procedures, along with the recovery process. Although 5-year survival in lung cancer has increased to 60%, there is a general prejudice that lung cancer has a poor prognosis. A preliminary diagnosis of a such condition has consequently a negative effect on the mood and sleep patterns of the patients, starting already from the beginning of the diagnostic procedures. In our study, we want to evaluate the occurrence of sleep disorders, anxiety, depressive mood and functional outcomes before and 3 months after the surgical intervention. This would also help us to better identify the patients in need for professional support for sleep disorders as well as psychiatric conditions, and thus, a better management of patients with lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo lung resection with a pre-diagnosis of lung cancer
- •Being literate or having the physical strength to answer questions.
排除标准
- •The patient has a chronic disease such as dementia or treatment-resistant schizophrenia in which reality assessment is impaired.
- •Patients who have received chemotherapy and / or radiotherapy due to their previous disease.
结局指标
主要结局
Change from baseline in Restless Legs Syndrome questionnaire scores
时间窗: 3 months
Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms
Change from baseline in Insomnia questionnaire scores
时间窗: 3 months
Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.
Change from baseline in Epworth Sleepiness Scale scores
时间窗: 3 months
Excessive daytime sleepiness. Score range: 0-24 points, with higher scores indicating greater daytime sleepiness. Scores ≥11 are generally considered to be abnormal, or positive for excessive daytime sleepiness.
Change from baseline in Berlin Questionnaire scores
时间窗: 3 months
High-risk Obstructive Sleep Apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.
Change from baseline in Functional Outcome of Sleep Questionnaire scores
时间窗: 3 months
Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status.
Change from baseline in STOP-BANG questionnaire scores
时间窗: 3 months
High-risk Obstructive Sleep Apnea. Score range: 0-8 points, patients with a STOP-Bang score of 0 to 2 can be classified as low risk for moderate to severe OSA whereas those with a score of 5 to 8 can be classified as high risk for moderate to severe OSA. The STOP-BANG is an assessment tool used to help diagnose Obstructive Sleep Apnea
次要结局
- Change from baseline in Beck Anxiety Inventory scores(3 months)
- Change from baseline in Zung Self-rating Depression Scale scores(3 months)