Study 6 of 72 for search of: "Confusion"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Delirium Recall in Advanced Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00493714
  Purpose

Primary Objectives:

  1. To determine the proportion of patients who experience partial or complete recollection of symptoms of delirium and the level of distress associated with this recall.
  2. To determine caregiver's level of distress associated with the patient's episode of delirium.

Condition Intervention
Advanced Cancer
Delirium
Behavioral: Questionnaire

MedlinePlus related topics: Cancer Caregivers
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 200
Study Start Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Presence of advanced cancer, defined as local recurrent and/or metastatic.
  2. History of an episode of delirium during the patient's current inpatient admission, diagnosis of delirium will be made by one of the palliative care specialists according to DSM-IV-TR criteria.
  3. If the patient has a complete recovery from the episode of delirium, the patient must be approached within 3 days for the possibility of inclusion in study. "Complete recovery" will be defined as diagnosis of complete resolution of all symptoms of delirium according to DSM-IV-TR criteria by one of the palliative care specialists.
  4. Ability to communicate in the English language.
  5. Caregiver who is 18 years of age or older (assessments used in this study have not been validated in pediatric population), is able to communicate in English and comprehend the assessment questionnaire, and is at the bedside for a significant length of time (approximately 4 hours) each day during the delirium episode. Both the patient and their caregiver must agree to participate for inclusion in the study.
  6. Written informed consent signed by the patients and the participating caregivers.
  7. MDAS [Memorial Delirium Assessment Scale] < 13 (Scores of 13 or above likely reflect the presence of delirium).
  8. Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit.

Exclusion Criteria:

  1. Refusal of both the patient and their caregiver to complete assessments
  2. Inability to complete assessment due to sensorial deficits other than cognition; e.g. blindness, deafness, aphasia, etc., that might impact the patient's ability to recall the episode of delirium.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493714

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eduardo Bruera, MD U.T.M.D. Anderson Cancer Center
  More Information

Study ID Numbers: 2005-0341
Study First Received: June 27, 2007
Last Updated: September 6, 2007
ClinicalTrials.gov Identifier: NCT00493714  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Delirium
Restlessness
Confusion
Caregivers
Questionnaire

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Confusion
Psychomotor Agitation
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009