进入姑息和支持治疗病房的患者的语言理解和认知过程评估
你能听到我吗?患者生命最后几天的语言理解和认知过程评估
This study investigates the use electroencephalography (EEG - a test that measures brain waves) to learn if patients who appear unresponsive (do not respond to noises, words, or touch) retain any consciousness. Families want to know if their loved ones who are unresponsive can still hear them or feel any discomfort. Information gained from this study may have important impact in how patients, caregivers, and doctors make decisions.
研究概览
地位
详细说明
PRIMARY OBJECTIVES:
I. To estimate the magnitude of electroencephalography (EEG) response to verbal stimuli among cancer patients in the last days in life admitted to a palliative and supportive care unit (PSCU).
II. To examine the feasibility of conducting EEG in cancer patients in the last days of life.
SECONDARY OBJECTIVES:
I. To compare the magnitude of EEG response between impending death cohort and control cohort.
II. To determine the association between the magnitude of EEG response and clinical assessments (e.g. JFK Coma Recovery Scale-Revised [CRS-R], Glasgow Coma Scale [GCS], Richmond Agitation Sedation Scale [RASS], Memorial Delirium Assessment Scale [MDAS]) in impending death cohort and control cohort separately.
III. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.
IV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.
OUTLINE:
Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.
研究类型
注册 (估计的)
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- M D Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with advanced cancer admitted to the palliative and supportive care unit at M.D. Anderson Cancer Center
描述
Inclusion Criteria:
- [Both cohorts] Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)
- [Both cohorts] Admitted to the PSCU at MD Anderson Cancer Center or seen by the specialist palliative care inpatient consultation team (control cohort only)
- [Impending death cohort] Clinician judgement of .3 days of survival or .1 late sign of impending death*
- [Impending death cohort] Palliative Performance Scale score of 10-20%
- [Control cohort] Able to communicate for the past 24 hours
- [Control cohort] Clinician judgement of .1 month of survival
- [Both cohorts] English-speaking
Exclusion Criteria:
- [Both cohorts] Hearing impairment that significantly impacts daily communication with caregiver prior to entering impending death phase OR requiring hearing aid
- [Impending death cohort] Mental status changes only related to medications as per clinician judgement
- [Control cohort] Diagnosis of delirium (i.e. MDAS .13)
- [Both cohorts] Pregnant women
- [Both Cohorts] Age < 18 years old
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Observational (EEG, questionnaires)
Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate. |
Complete questionnaires Undergo EEG
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients
大体时间:Day 1 in palliative and supportive care unit
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The magnitudes of EEG responses in each task will be calculated as the difference between pre-stimulus and post-stimulus, separately. 95% confidence intervals will be estimated for each task. |
Day 1 in palliative and supportive care unit
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合作者和调查者
调查人员
- 首席研究员:David Hui、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.