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

NCT05837039 | Recruiting

• 2 other identifiers: 2021-1177NCI-2022-02412
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoactive Delirium

Outcome Measures

Primary Outcomes (1)

• Likert Scale Survey

  Score Scales: (1-5) 1. Strongly Disagree 2. Disagree 3. Neither Agree Nor Disagree 4. Agree 5. Strongly Agree

  through study completion; an average of 1 year.

Study Arms (1)

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

Behavioral: Healthcare Provider; Behavioral: Caregiver Perception

Interventions

Healthcare Provider BEHAVIORAL

Questionnaires

Healthcare Provider and Caregiver Perception of Discomfort

Caregiver Perception BEHAVIORAL

Questionnaires

Healthcare Provider and Caregiver Perception of Discomfort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

M D Anderson Cancer Center

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Michael Tang, MD

  University of M D Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tang, MD

CONTACT

(832) 468-8895; mjtang@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)