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Trial Title:
A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
NCT ID:
NCT05837039
Condition:
Hypoactive Delirium
Conditions: Official terms:
Delirium
Hypokinesia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Behavioral
Intervention name:
Healthcare Provider
Description:
Questionnaires
Arm group label:
Healthcare Provider and Caregiver Perception of Discomfort
Intervention type:
Behavioral
Intervention name:
Caregiver Perception
Description:
Questionnaires
Arm group label:
Healthcare Provider and Caregiver Perception of Discomfort
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
Detailed description:
Primary Objective:
To assess the caregiver's perception of the level of discomfort of patients who have a
hypoactive delirium and who are considered actively dying. The caregiver's perception
will be based upon the Caregiver Survey of Patient Discomfort.
Secondary Objective:
To compare the perception of discomfort between the caregiver and bedside nurse. The
caregiver's perception will be based upon the Caregiver Survey of Patient Discomfort, and
the nurse's perception will be based upon the Healthcare Provider Survey of Patient
Discomfort.
Exploratory Objective:
To assess associations between patient demographics and clinical characteristics as well
as caregiver and nurse demographics on corresponding caregiver and nurse survey
responses.
Criteria for eligibility:
Study pop:
M D Anderson Cancer Center
Sampling method:
Non-Probability Sample
Criteria:
Patient Inclusion Criteria:
1. Patients with advanced cancer. Advanced cancer is defined as locally invasive,
metastatic or recurrent cancer. Hematologic malignancies will also be included.
2. Patients who are admitted to the acute palliative care unit (APCU) at MD Anderson
Cancer Center.
3. 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.
4. 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.16,17 The presence of these signs will be based on the reporting
of the attending physician, fellow physicians or nursing staff of the APCU.
5. 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:
1. 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.
2. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Micheal Tang, MD
Phone:
(832) 468-8895
Email:
mjtang@mdanderson.org
Contact backup:
Last name:
Micheal Tang, MD
Start date:
March 25, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05837039
http://www.mdanderson.org
