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

NCT05091632 | Suspended

• 2 other identifiers: 2019-1079NCI-2021-08958
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Electroencephalography PROCEDURE

Undergo EEG

Also known as: EEG, electroencephalogram

Observational (EEG, questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Observational (EEG, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \[Both cohorts\] 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

You may not qualify if:

• \[Both cohorts\] 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Hui

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 25, 2021
• Study Start: May 4, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)