Hematopoietic and Lymphoid Cell NeoplasmNCT05091632
Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Electroencephalography and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 2 Feb 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced cancer admitted to the palliative and supportive care unit at M.D. Anderson Cancer Center
Who may be able to join
- [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
Who cannot join
- [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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Electroencephalography, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyProcedure or surgery
Also called EEG, electroencephalogram
Undergo EEG
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electroencephalography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 in palliative and supportive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start4 May 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091632
- Sponsor's protocol ID
- 2019-1079
- Other IDs
- NCI-2021-08958, 2019-1079
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life
- ClinicalTrials.gov ID
- NCT05091632
- Acronym / sponsor ID
- 2019-1079
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: PI Request
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (EEG, questionnaires) | – | Procedure: Electroencephalography, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer admitted to the palliative and supportive care unit at M.D. Anderson Cancer Center
Key inclusion criteria (7 listed)
- [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
Key exclusion criteria (5 listed)
- [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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalographyAlso: EEG, electroencephalogramUndergo EEG | Procedure or surgery | Observational (EEG, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (EEG, questionnaires) |
Primary outcome
Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients
Time frame: Day 1 in palliative and supportive care unit
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hui principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients (time frame: Day 1 in palliative and supportive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.