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

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ClinicalTrials.gov Identifier: NCT05091632
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm Procedure: Electroencephalography Other: Questionnaire Administration

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life
Actual Study Start Date : May 4, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023
Groups and Cohorts
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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.
 Procedure: Electroencephalography
Undergo EEG
Other Names:
  • EEG
  • electroencephalogram

Other: Questionnaire Administration
Complete questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

  • IMPENDING DEATH COHORT: Clinician judgement of =< 3 days of survival or >= 1 late sign of impending death

    • Presence of late signs of impending death are based on reporting by bedside nurses, physicians, or research staff. Examples of these signs include inability to close eyelids; non-reactive pupils; drooping of nasolabial fold; hyperextension of neck; death rattle; grunting of vocal cords; decreased response to verbal/visual stimuli; respiration with mandibular movement; Cheyne Stokes breathing; pulselessness of radial artery; peripheral cyanosis; or decreased urine output
  • IMPENDING DEATH COHORT: Glasgow Coma Scale =< 8
  • IMPENDING DEATH COHORT: Not been able to communicate for past 24 hours (no verbal response) because of delirium, coma, or impending death based on the judgement of the palliative care unit physician.
  • 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: Evidence of brain metastases, brain hemorrhage, or subdural hematomas on recent neuroimaging
  • BOTH COHORTS: Hearing impairment as documented by chart or requiring hearing aid
  • IMPENDING DEATH COHORT: Mental status changes predominantly related to medications as per clinician judgement
  • CONTROL COHORT: Diagnosis of delirium (i.e. Memorial Delirium Assessment Scale [MDAS] >= 13)
  • BOTH COHORTS: Pregnant women
  • BOTH COHORTS: Age < 18 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091632


Contacts
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Contact: David Hui 713-792-6085 dhui@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David Hui    713-792-6085    dhui@mdanderson.org   
Principal Investigator: David Hui         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: David Hui M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05091632    
Other Study ID Numbers: 2019-1079
NCI-2021-08958 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1079 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Neoplasms