Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT05091632
Status:
SUSPENDED
Last Update Posted:
2025-10-27
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'PI Request', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of electroencephalography (EEG) response to verbal stimuli among impending death cancer patients', 'timeFrame': 'Day 1 in palliative and supportive care unit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Locally Advanced Malignant Solid Neoplasm', 'Metastatic Malignant Solid Neoplasm', 'Recurrent Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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).\n\nII. To examine the feasibility of conducting EEG in cancer patients in the last days of life.\n\nSECONDARY OBJECTIVES:\n\nI. To compare the magnitude of EEG response between impending death cohort and control cohort.\n\nII. 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.\n\nIII. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.\n\nIV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.\n\nOUTLINE:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced cancer admitted to the palliative and supportive care unit at M.D. Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\[Both cohorts\\] Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)\n2. \\[Both cohorts\\] Admitted to the PSCU at MD Anderson Cancer Center or seen by the specialist palliative care inpatient consultation team (control cohort only)\n3. \\[Impending death cohort\\] Clinician judgement of .3 days of survival or .1 late sign of impending death\\*\n4. \\[Impending death cohort\\] Palliative Performance Scale score of 10-20%\n5. \\[Control cohort\\] Able to communicate for the past 24 hours\n6. \\[Control cohort\\] Clinician judgement of .1 month of survival\n7. \\[Both cohorts\\] English-speaking\n\nExclusion Criteria:\n\n1. \\[Both cohorts\\] Hearing impairment that significantly impacts daily communication with caregiver prior to entering impending death phase OR requiring hearing aid\n2. \\[Impending death cohort\\] Mental status changes only related to medications as per clinician judgement\n3. \\[Control cohort\\] Diagnosis of delirium (i.e. MDAS .13)\n4. \\[Both cohorts\\] Pregnant women\n5. \\[Both Cohorts\\] Age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT05091632', 'briefTitle': 'Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life', 'orgStudyIdInfo': {'id': '2019-1079'}, 'secondaryIdInfos': [{'id': 'NCI-2021-08958', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-1079', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (EEG, questionnaires)', 'description': '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.', 'interventionNames': ['Procedure: Electroencephalography', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Electroencephalography', 'type': 'PROCEDURE', 'otherNames': ['EEG', 'electroencephalogram'], 'description': 'Undergo EEG', 'armGroupLabels': ['Observational (EEG, questionnaires)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (EEG, questionnaires)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}