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A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium

A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05837039
Enrollment
100
Registered
2023-05-01
Start date
2024-03-25
Completion date
2027-12-31
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Delirium

Brief 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.

Interventions

BEHAVIORALHealthcare Provider

Questionnaires

BEHAVIORALCaregiver Perception

Questionnaires

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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 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.

Design outcomes

Primary

MeasureTime frameDescription
Likert Scale Surveythrough 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

Countries

United States

Contacts

CONTACTMichael Tang, MD
mjtang@mdanderson.org(832) 468-8895
PRINCIPAL_INVESTIGATORMichael Tang, MD

University of M D Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026