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The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers


N/A
18 Years
N/A
Not Enrolling
Both
Advanced Cancer, Delirium

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Trial Information

The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers


Informed Consent for Patients:

Delirium is often seen in patients with advanced cancer. Delirium is defined as confusion
and restlessness. In this study, cancer patients will be asked about their memory of
experiencing delirium and the distress related to those memories. Caregivers of those
patients will also be asked to participate, and they will be asked questions about their
experience during these situations.

You will be tested using the Memorial Delirium Assessment Scale to see if you have recovered
from your delirium. If you are still eligible to take part in this study, and both you and
your caregiver agree to participate in this study; you will be asked by the research nurse
to complete several questionnaires that ask questions about your mental state, any memory of
experiencing delirium, the severity of the delirium, symptoms you experienced during the
delirium episode, and your level of emotional distress related to that event. If you and
your caregiver are asked to participate in this study; you will also be asked "open-ended"
questions (questions with no wrong answers) regarding the experience you had during the
severe episode of delirium; your memories of the experience, and the overall distress
related to it. This conversation will be tape recorded, and it will be written down
word-for-word, for the purpose of analysis. The conversation is expected to last no more
than 30 minutes.

The assessments and questionnaires will be conducted only at the time of interview. No
further assessments or questions will be done after the completion of the study. All
information collected for the study will be kept confidential. You will be assigned a study
participant number when you enroll on the study, and this number will be used (instead of
your name) on all data collections, to protect your confidentiality.

This is an investigational study. Up to 100 patients and 100 caregivers will take part in
this study. All will be enrolled at M. D. Anderson.

Informed Consent for Caregivers:

Delirium is often seen in patients with advanced cancer. Delirium is defined as confusion
and restlessness.

In this study, you will be asked about your memory of your family member's experience of
delirium, and the distress related to those memories. The patient you are caring for will
also be asked to participate, and they will be asked questions about their experience during
these situations.

If you are eligible to take part in this study, and both you and your family member agree to
participate in this study, you will be asked by the research nurse to complete several
questionnaires that ask questions about your family member's mental state, your memory of
your family member's experience of delirium, the severity of the delirium, symptoms your
family member experienced during the delirium episode, and your level of emotional distress
related to that event. If you and your caregiver are asked to participate in this study;
you will also be asked "open-ended" questions (questions with no wrong answers) regarding
the experience you had during your family member's severe episode of delirium, your memories
of the experience, and the overall distress related to it. This conversation will be
recorded using a tape recorder, and it will be written down word for word, for the purpose
of analysis. The conversation is expected to last no more than 30 minutes.

The assessments and questionnaires will be conducted only at the time of interview. No
further assessments or questions will be done after the completion of the study. All
information collected for the study will be kept confidential. You will be assigned a study
participant number when you enroll on the study, and this number will be used (instead of
your name) on all data collections, to protect your confidentiality.

This is an investigational study. Up to 100 cancer patients and 100 caregivers will take
part in this study. All will be enrolled at M. D. Anderson.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Patient Level of Distress as related to Level of Delirium

Outcome Description:

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.

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Eduardo Bruera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0341

NCT ID:

NCT00493714

Start Date:

July 2005

Completion Date:

December 2007

Related Keywords:

  • Advanced Cancer
  • Delirium
  • Advanced Cancer
  • Delirium
  • Restlessness
  • Confusion
  • Caregivers
  • Questionnaire
  • Delirium
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030