Assessment of Verbal Comprehension and Cognitive Processe... | NCT05091632

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

NCT05091632

Sponsor

M.D. Anderson Cancer Center

Status

Suspended

Last Update Posted

Apr 15, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

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

Interventions

Electroencephalography
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2021-08958	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2019-1079	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI Request

Expanded Access Info

Start Date

May 4, 2021Actual

Primary Completion Date

Feb 2, 2027Estimated

Completion Date

Feb 2, 2027Estimated

First Submitted Date

Sep 28, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: Electroencephalography Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electroencephalography	Procedure	Undergo EEG	Observational (EEG, questionnaires)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 or seen by the specialist palliative care inpatient consultation team (control cohort only)
[Impending death cohort] Clinician judgement of .3 days of survival or .1 late sign of impending death*
[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] Hearing impairment that significantly impacts daily communication with caregiver prior to entering impending death phase OR requiring hearing aid
[Impending death cohort] Mental status changes only related to medications as per clinician judgement
[Control cohort] Diagnosis of delirium (i.e. MDAS .13)
[Both cohorts] Pregnant women
[Both Cohorts] Age < 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced cancer admitted to the palliative and supportive care unit at M.D. Anderson Cancer Center

Sampling Method

Non-Probability Sample

ID	Term
D019337	Hematologic Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms