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临床试验/NCT06495346
NCT06495346已完成不适用

Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Score sleep quality criteria (Pittsburgh Sleep Quality Index)

研究概览

简要总结

This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.

This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.

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

入选标准

  • Patient aged 18 and over.
  • Being monitored and treated for non-small cell lung cancer.
  • With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
  • With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG <2).
  • Able to understand the study documents written in French
  • Able to complete the study questionnaires written in French.
  • Contactable by telephone throughout the study
  • Affiliated to a social security scheme or entitled beneficiary
  • Not opposed to taking part in the study

排除标准

  • Patient refusing to take part in the study
  • With a mental illness of the psychosis type monitored and treated prior to the study
  • Patient under guardianship or curatorship
  • Patient under court protection

结局指标

主要结局

Score sleep quality criteria (Pittsburgh Sleep Quality Index)

时间窗: Every 14 days for 2 months

The overall score ranging from 0 to 21 points. A score of 0 means that there is no difficulty sleeping, and 21 indicates, on the contrary, major difficulties.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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