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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    30
  • sponsor
    M.D. Anderson Cancer Center
Updated on 4 October 2022
cancer

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.

Details
Condition Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
Treatment questionnaire administration, Electroencephalography
Clinical Study IdentifierNCT05091632
SponsorM.D. Anderson Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
IMPENDING DEATH COHORT: Clinician judgement of =< 3 days of survival or >= 1 late sign of impending death
Presence of late signs of impending death are based on reporting by bedside nurses, physicians, or research staff. Examples of these signs include inability to close eyelids; non-reactive pupils; drooping of nasolabial fold; hyperextension of neck; death rattle; grunting of vocal cords; decreased response to verbal/visual stimuli; respiration with mandibular movement; Cheyne Stokes breathing; pulselessness of radial artery; peripheral cyanosis; or decreased urine output
IMPENDING DEATH COHORT: Glasgow Coma Scale =< 8
IMPENDING DEATH COHORT: Not been able to communicate for past 24 hours (no verbal response) because of delirium, coma, or impending death based on the judgement of the palliative care unit physician
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: Evidence of brain metastases, brain hemorrhage, or subdural hematomas on recent neuroimaging
BOTH COHORTS: Hearing impairment as documented by chart or requiring hearing aid
IMPENDING DEATH COHORT: Mental status changes predominantly related to medications as per clinician judgement
CONTROL COHORT: Diagnosis of delirium (i.e. Memorial Delirium Assessment Scale [MDAS] >= 13)
BOTH COHORTS: Pregnant women
BOTH COHORTS: Age < 18 years old
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