Delirium Recall in Advanced Cancer Patients

NCT00493714 | Completed

• 1 other identifier: 2005-0341
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 2.To determine caregiver's level of distress associated with the patient's episode of delirium.

Conditions

Advanced Cancer; Delirium

Keywords

Advanced Cancer; Delirium; Restlessness; Confusion; Caregivers; Questionnaire

Outcome Measures

Primary Outcomes (2)

• Patient Level of Distress as related to Level of Delirium

  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.

  2 Years

• Number of patients who have partial or complete memory of experiencing any signs of delirium (confusion or restlessness)

  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

  2 Years

Study Arms (2)

Arm 1 (Patient)

Cancer patient who recently experienced confusion or restlessness.

Behavioral: Questionnaire

Arm 2 (Caregiver)

Caregivers of cancer patients who recently experienced confusion or restlessness.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Surveys lasting 30 minutes or more.

Arm 1 (Patient); Arm 2 (Caregiver)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Presence of advanced cancer, defined as local recurrent and/or metastatic.
• 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.
• Ability to communicate in the English language.
• Written informed consent signed by the patients and the participating caregivers.
• MDAS \[Memorial Delirium Assessment Scale\] \< 13 (Scores of 13 or above likely reflect the presence of delirium).
• Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit.

You may not qualify if:

• Refusal of both the patient and their caregiver to complete assessments
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Delirium; Psychomotor Agitation; Confusion

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eduardo Bruera, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)