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

Suspended

• Conditions: Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm
• Interventions: Procedure: Electroencephalography; Other: Questionnaire Administration

• Registration Number: NCT05091632
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (EEG, questionnaires)	Questionnaire Administration	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.
Observational (EEG, questionnaires)	Electroencephalography	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.

Primary Outcome Measures

Name	Time	Method
Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States