Advanced Malignant NeoplasmNCT03671226
Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center
A study testing Questionnaire Administration in people with Advanced Malignant Neoplasm and Caregiver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Caregiver, Locally Advanced Malignant Neoplasm
- What is being tested?
- Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient: Have advanced cancer, defined as locally advanced, metastatic or incurable disease.
- Patient: Seen at University of Texas M. D. Anderson Cancer Center (UTMDACC) outpatient Supportive Care Center for consultation (first visit).
- Patient: Provided informed consent.
- Patient: Can read and speak English or Spanish.
- Patient: Has a consenting caregiver at the time of the Supportive Care consultation visit.
- Caregiver: Provided informed consent.
- Caregiver: Can read and speak English or Spanish.
- Caregiver: Must be with consenting patient at the time of the Supportive Care consultation visit.
Who cannot join
- Patient: Delirium diagnosed by palliative care physician or nurse and/or Memorial Delirium Assessment Scale (MDAS) >= 7 or dementia.
- Patient: Inability to read and speak English or Spanish.
- Patient: No caregiver at the time of Supportive Care consultation visit.
- Caregiver: Inability to read and speak English or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception of Supportive Care Patients and Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center Regarding the Preference of Room Setting and Waiting Time
This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Room setting preferences of patients and caregivers may help to understand their opinion regarding direct rooming system in the outpatient supportive/palliative care center.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine patients and caregivers preferences regarding the rooming process in outpatient supportive palliative care clinic, measured by the preference to exam room versus waiting area.
SECONDARY OBJECTIVES:
- Patients and caregiver perceptions regarding room setting and waiting time in the outpatient supportive care clinic.
II. Extent/experience of team contact in the outpatient supportive care clinic. III. The factors associated with rooming preferences such as age, gender, symptom distress and performance status.
IV. The association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and perception of usefulness of the visit to palliative care center.
- The attitudes and beliefs toward usefulness of referral to outpatient palliative care.
VI. The correlation between the patient and caregivers preferences.
OUTLINE:
Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit.
- Conditions
- Advanced Malignant Neoplasm, Caregiver, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- Being tested
- Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Given questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (questionnaire) | Experimental | Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of exam room over waiting room as soon as checking in until the nurse is ready for a patient assessed using questionnaire
Two sample t-test or Wilcoxon rank sum test, whichever more appropriate, will be used to compare continuous variables of interest between the preference of exam room over waiting area. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between each of categorical variables and preference of exam room over waiting area. Univariate/multicovariate logistic regression analysis will be used to explore the demographics and clinical factors associated with rooming preferences.
Measured: Up to 3 days after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start28 Sep 2018
- 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 Advanced Malignant NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- MarieBerta Vidal, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671226
- Sponsor's protocol ID
- 2018-0573
- Other IDs
- NCI-2018-01877, 2018-0573
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2018
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Supportive Care Patients and Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center Regarding the Preference of Room Setting and Waiting Time
- ClinicalTrials.gov ID
- NCT03671226
- Acronym / sponsor ID
- 2018-0573
- Conditions
- Advanced Malignant Neoplasm, Caregiver, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 406 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2018 (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.
This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Room setting preferences of patients and caregivers may help to understand their opinion regarding direct rooming system in the outpatient supportive/palliative care center.
Detailed description
PRIMARY OBJECTIVES:
- To determine patients and caregivers preferences regarding the rooming process in outpatient supportive palliative care clinic, measured by the preference to exam room versus waiting area.
SECONDARY OBJECTIVES:
- Patients and caregiver perceptions regarding room setting and waiting time in the outpatient supportive care clinic.
II. Extent/experience of team contact in the outpatient supportive care clinic. III. The factors associated with rooming preferences such as age, gender, symptom distress and performance status.
IV. The association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and perception of usefulness of the visit to palliative care center.
- The attitudes and beliefs toward usefulness of referral to outpatient palliative care.
VI. The correlation between the patient and caregivers preferences.
OUTLINE:
Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (questionnaire) | Experimental | Other: Questionnaire AdministrationPatients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient: Have advanced cancer, defined as locally advanced, metastatic or incurable disease.
- Patient: Seen at University of Texas M. D. Anderson Cancer Center (UTMDACC) outpatient Supportive Care Center for consultation (first visit).
- Patient: Provided informed consent.
- Patient: Can read and speak English or Spanish.
- Patient: Has a consenting caregiver at the time of the Supportive Care consultation visit.
Key exclusion criteria (4 listed)
- Patient: Delirium diagnosed by palliative care physician or nurse and/or Memorial Delirium Assessment Scale (MDAS) >= 7 or dementia.
- Patient: Inability to read and speak English or Spanish.
- Patient: No caregiver at the time of Supportive Care consultation visit.
- Caregiver: Inability to read and speak English or Spanish.
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 |
|---|---|---|
| Questionnaire AdministrationGiven questionnaire | Other | Supportive Care (questionnaire) |
Primary outcome
Preference of exam room over waiting room as soon as checking in until the nurse is ready for a patient assessed using questionnaire
Time frame: Up to 3 days after visit
Two sample t-test or Wilcoxon rank sum test, whichever more appropriate, will be used to compare continuous variables of interest between the preference of exam room over waiting area. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between each of categorical variables and preference of exam room over waiting area. Univariate/multicovariate logistic regression analysis will be used to explore the demographics and clinical factors associated with rooming preferences.
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 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
MarieBerta Vidal principal investigator
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?
A study testing Questionnaire Administration in people with Advanced Malignant Neoplasm and Caregiver, 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?
The sponsor lists 8 inclusion and 4 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference of exam room over waiting room as soon as checking in until the nurse is ready for a patient assessed using questionnaire (time frame: Up to 3 days after visit). 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 6 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.