Hypoactive DeliriumNCT05837039
A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
An observational study of Hypoactive Delirium, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoactive Delirium
- What is being tested?
- Healthcare Provider and Caregiver Perception
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Patient 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.
Patient 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.
- A family member or caregiver who cannot provide informed consent, or who cannot speak and read English.
Caregiver Inclusion Criteria:
- 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:
- Nursing providers in the acute palliative care unit who are providing direct patient care to eligible patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Micheal Tang, MD, 832-468-8895, mjtang@mdanderson.org
Micheal Tang, MD
About this study
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
Read the 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
- Being tested
- Healthcare Provider, Caregiver Perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare ProviderBehavioural
Questionnaires
Caregiver PerceptionBehavioural
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Healthcare Provider; Behavioral: Caregiver Perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert Scale Survey
Score Scales: (1-5)
- Strongly Disagree
- Disagree
- Neither Agree Nor Disagree
- Agree
- Strongly Agree
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start25 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive DeliriumStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Tang, MD, Principal investigator, University of M D Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837039
- Sponsor's protocol ID
- 2021-1177
- Other IDs
- NCI-2022-02412
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
- ClinicalTrials.gov ID
- NCT05837039
- Acronym / sponsor ID
- 2021-1177
- Conditions
- Hypoactive Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Provider and Caregiver Perception of Discomfort | – | Behavioral: Healthcare Provider, Behavioral: Caregiver PerceptionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthcare ProviderQuestionnaires | Behavioural | Healthcare Provider and Caregiver Perception of Discomfort |
| Caregiver PerceptionQuestionnaires | Behavioural | Healthcare Provider and Caregiver Perception of Discomfort |
Primary outcome
Likert Scale Survey
Time frame: through 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Hypoactive Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Tang, MD principal investigator
University of M D Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoactive Delirium, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tang, MD ((832) 468-8895, mjtang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert Scale Survey (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.