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

NCT ID: NCT05837039

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2027-12-31

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.

Conditions

Hypoactive Delirium

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthcare Provider and Caregiver Perception of Discomfort

Participants will be providing demographic information about you (age, sex/gender, race, ethnicity, educational level, if the participant are in the same household as the patient, if participants are the primary caregiver of the patient, and whether you live in a rural, suburban, or urban environment) Your feelings about your loved one's comfort level Your feelings about symptoms you think affect comfort level Behaviors seen while at the bedside of your loved one

Healthcare Provider

Intervention Type: BEHAVIORAL

Questionnaires

Caregiver Perception

Intervention Type: BEHAVIORAL

Questionnaires

Interventions

Healthcare Provider

Questionnaires

Intervention Type: BEHAVIORAL

Caregiver Perception

Questionnaires

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

1. Nursing providers in the acute palliative care unit who are providing direct patient care to eligible patients.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Tang, MD

Role: PRINCIPAL_INVESTIGATOR

University of M D Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Tang, MD

Role: CONTACT

mjtang@mdanderson.org

(832) 468-8895

Facility Contacts

Micheal Tang, MD

Role: primary

mjtang@mdanderson.org

832-468-8895

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2022-02412

Identifier Type: OTHER

Identifier Source: secondary_id

2021-1177

Identifier Type: -

Identifier Source: org_study_id