Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients
研究概览
简要总结
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.
详细描述
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.
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
- •[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
排除标准
- •[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
研究组 & 干预措施
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.
干预措施: Electroencephalography (Procedure)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients
时间窗: Day 1 in palliative and supportive care unit
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.
次要结局
未报告次要终点