Delirium Recall in Advanced Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00493714
First received: June 27, 2007
Last updated: July 27, 2012
Last verified: July 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Level of Distress as related to Level of Delirium [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Level of distress patients experience associated with delirium recall, made on a 0-4 numerical rating scale with 0=not at all and 4=extremely distressed. Summarized as a median score and as the most frequent response.

  • Number of patients who have partial or complete memory of experiencing any signs of delirium (confusion or restlessness) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Interview with full assessment including demographic information, MMSE (Mini-Mental State Exam), DEQ (The Delirium Experience Questionnaire), and Delirium Recall Questionnaire for patient who experience complete recovery from an episode of delirium


Enrollment: 200
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 (Patient)
Cancer patient who recently experienced confusion or restlessness.
Behavioral: Questionnaire
Surveys lasting 30 minutes or more.
Arm 2 (Caregiver)
Caregivers of cancer patients who recently experienced confusion or restlessness.
Behavioral: Questionnaire
Surveys lasting 30 minutes or more.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Advanced cancer patient having had an episode of delirium with complete recover; and their caregivers, age 18 years or older.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493714

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00493714     History of Changes
Other Study ID Numbers: 2005-0341
Study First Received: June 27, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014