Delirium Recall in Advanced Cancer Patients

Advanced Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer
• Delirium
• Neoplasms

• NCT number: NCT00493714
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: N/A
• Start date: July 2005
• Completion date: December 2007