Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05091632
• Other study ID #: 2019-1079
• Secondary ID: NCI-2021-0895820
• Status: Suspended
• Start date: May 4, 2021
• Est. completion date: February 2, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. [Both cohorts] Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)

2. [Both cohorts] Admitted to the PSCU at MD Anderson Cancer Center or seen by the specialist palliative care inpatient consultation team (control cohort only)

3. [Impending death cohort] Clinician judgement of .3 days of survival or .1 late sign of impending death*

4. [Impending death cohort] Palliative Performance Scale score of 10-20%

5. [Control cohort] Able to communicate for the past 24 hours

6. [Control cohort] Clinician judgement of .1 month of survival

7. [Both cohorts] English-speaking

Exclusion Criteria:

1. [Both cohorts] Hearing impairment that significantly impacts daily communication with caregiver prior to entering impending death phase OR requiring hearing aid

2. [Impending death cohort] Mental status changes only related to medications as per clinician judgement

3. [Control cohort] Diagnosis of delirium (i.e. MDAS .13)

4. [Both cohorts] Pregnant women

5. [Both Cohorts] Age < 18 years old

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Locally Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms
• Recurrent Malignant Solid Neoplasm

Intervention

Procedure:
• Electroencephalography
Undergo EEG

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients	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

External Links

•   MD Anderson Cancer Center