A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Pat… (NCT05837039) | Clinical Trial Compass
RecruitingNot Applicable
A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
United States100 participantsStarted 2024-03-25
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Likert Scale Survey
Timeframe: through study completion; an average of 1 year.