跳至主要内容
临床试验/NCT05414357
NCT05414357招募中不适用

Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer

Centre Francois Baclesse4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
4
主要终点
Ratio of total sleep time to time spent in bed and the number of awakenings lasting more than one minute measured by polysomnography with actimeter

研究概览

简要总结

Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 39 to 69 years
  • Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy
  • Patient with education level 3 "end of primary education"
  • Patient with a good command of the French language
  • Patient with access to the Internet from a computer at home
  • Patient having signed the consent to participate in the study
  • Patient with no pre-existing cognitive impairment at the time of cancer diagnosis
  • Patient with a sleep complaint (ISI > 7)

排除标准

  • Patient with metastatic cancer
  • Patient with a primary cancer other than breast cancer
  • Patient with a history of neurological damage
  • Patient with treated sleep apnea
  • Patient with drug use or alcohol abuse (≥3 drinks/day on average and/or >10 drinks/week)
  • Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics)
  • Patient with a personality disorder and/or an evolving psychiatric pathology
  • Patient with a contraindication to MRI (claustrophobia, metallic objects in the body)
  • Patient with an uncorrected vision problem

结局指标

主要结局

Ratio of total sleep time to time spent in bed and the number of awakenings lasting more than one minute measured by polysomnography with actimeter

时间窗: At 6 months

Amplitude of activity-rest rhythm measured with actimeter

时间窗: At 6 months

Acrophase of activity-rest rhythm measured with actimeter

时间窗: At 6 months

次要结局

未报告次要终点

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (4)

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