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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Electroencephalography

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: David Hui; Phone Number: 713-792-6085; Email: DHui@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: David Hui; Phone Number: 713-792-6085; Email: DHui@mdanderson.org
      • Principal Investigator: David Hui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaire Administration; Complete questionnaires; Procedure: Electroencephalography; Undergo EEG; Other Names: EEG; electroencephalogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: David Hui, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2019-1079 (Other Identifier: M D Anderson Cancer Center); NCI-2021-08958 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No