Insomnia in Patients With Metastatic Non Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frequency of clinically significant insomnia
研究概览
简要总结
This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.
OUTLINE: This is an observational study.
Patients undergo medical chart review and complete a questionnaire on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Have a diagnosis of metastatic non small cell lung cancer
- •Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy
- •Older than 18 years old at the time of diagnosis
排除标准
- •Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review
研究组 & 干预措施
Observational
Patients undergo medical chart review and complete a questionnaire on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Frequency of clinically significant insomnia
时间窗: Baseline
Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe).
次要结局
未报告次要终点