Advanced CancerNCT00493714
Delirium Recall in Advanced Cancer Patients
An observational study of Advanced Cancer and Delirium, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Delirium
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Advanced cancer patient having had an episode of delirium with complete recover; and their caregivers, age 18 years or older.
Who may be able to join
- 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.
- 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.
- Ability to communicate in the English language.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers
Primary Objectives:
- 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.
- To determine caregiver's level of distress associated with the patient's episode of delirium.
Read the detailed 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.
- Conditions
- Advanced Cancer, Delirium
- Being tested
- Questionnaire
- Keywords
- Advanced Cancer, Delirium, Restlessness, Confusion, Caregivers, Questionnaire
- Medical subject headings
- Delirium, Psychomotor Agitation, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Surveys lasting 30 minutes or more.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Patient) | Cancer patient who recently experienced confusion or restlessness. Receives: Behavioral: Questionnaire | |
| Arm 2 (Caregiver) | Caregivers of cancer patients who recently experienced confusion or restlessness. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493714
- Sponsor's protocol ID
- 2005-0341
- Status last verified
- Jul 2012
- First submitted
- 27 Jun 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers
- ClinicalTrials.gov ID
- NCT00493714
- Acronym / sponsor ID
- 2005-0341
- Conditions
- Advanced Cancer, Delirium
- Keywords
- Advanced Cancer, Delirium, Restlessness, Confusion, Caregivers, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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.
- To determine caregiver's level of distress associated with the patient's episode of delirium.
Detailed 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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Patient) | – | Behavioral: QuestionnaireCancer patient who recently experienced confusion or restlessness. |
| Arm 2 (Caregiver) | – | Behavioral: QuestionnaireCaregivers of cancer patients who recently experienced confusion or restlessness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced cancer patient having had an episode of delirium with complete recover; and their caregivers, age 18 years or older.
Key inclusion criteria (8 listed)
- 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.
- 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.
- Ability to communicate in the English language.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSurveys lasting 30 minutes or more. | Behavioural | Arm 1 (Patient), Arm 2 (Caregiver) |
Primary outcome
Patient Level of Distress as related to Level of Delirium
Time frame: 2 Years
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Delirium, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Level of Distress as related to Level of Delirium (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.