NCT05837039 · M.D. Anderson Cancer Center
A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
What this study is about
To learn about your feelings as a caregiver about the level of discomfort of patients who have hypoactive delirium (loss of contact and response to reality) and who are at the end of life
View original scientific description
To learn about your feelings as a caregiver about the level of discomfort of patients who have hypoactive delirium (loss of contact and response to reality) and who are at the end of life
Interventions
BEHAVIORAL
Healthcare Provider
Questionnaires
BEHAVIORAL
Caregiver Perception
Questionnaires
Primary outcome measures
Likert Scale Survey
Time frame: through study completion; an average of 1 year.
Score Scales: (1-5) 1. Strongly Disagree 2. Disagree 3. Neither Agree Nor Disagree 4. Agree 5. Strongly Agree
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with advanced cancer. Advanced cancer is defined as locally invasive, metastatic or recurrent cancer. Hematologic malignancies will also be included.
- Patients who are admitted to the acute palliative care unit (APCU) at MD Anderson Cancer Center.
- Patients who are unable to respond to questioning in the past 24 hours as determined by the attending physician, fellow physicians, or nursing staff of the APCU.
- Patients who are considered to be actively dying, as defined as likely to die during the admission and not regain consciousness. The physical exam findings that will be utilized to help define those patients who are actively dying may include one but not limited to one of the following symptoms: pulseless of the radial artery, Cheyne-stokes breathing, peripheral cyanosis, apnea periods, respiration with mandibular movement, turbulent airway noise produced on inspiration and/or expiration due to airway secretions commonly known as the "death rattle", and loss of nasolabial folds The presence of these signs will be based on the reporting of the attending physician, fellow physicians or nursing staff of the APCU.
- Patients who have an unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent and who has been present at bedside for at least 3 hours a day. Patient
Exclusion criteria
- Patients who had a hyperactive or mixed delirium in which they either had high level of arousal due to delirium or had mixed episodes of arousal and agitation with periods of unresponsiveness.
- A family member or caregiver who cannot provide informed consent, or who cannot speak and read English. Caregiver Inclusion Criteria: 1\. Unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent, able to speak and read English, and who has been present at bedside for at least 3 hours a day. Nursing Provider Inclusion Criteria: 1\. Nursing providers in the acute palliative care unit who are providing direct patient care to eligible patients.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations