Clinical trial NCT05091632: Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit
Official title: Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer admitted to the palliative and supportive care unit at 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.

Eligibility criteria: 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

Primary outcomes:
measure: Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients
timeFrame: Day 1 in palliative and supportive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui
role: PRINCIPAL_INVESTIGATOR
References: