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

NCT ID: NCT05091632

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2027-02-02

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Electroencephalography

Intervention Type: PROCEDURE

Undergo EEG

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Interventions

Electroencephalography

Undergo EEG

Intervention Type: PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Other Intervention Names

EEG; electroencephalogram

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hui

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2021-08958

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-1079

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1079

Identifier Type: -

Identifier Source: org_study_id