Metastatic Malignant Solid NeoplasmNCT05095948
Improving Processes of Cancer Care Delivery at a Comprehensive Cancer Center
An observational study of Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study examines how cancer care is delivered in oncology and supportive care clinics. Collecting patient feedback may help doctors better understand the processes of cancer care in oncology and supportive care clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Solid Neoplasm
- What is being tested?
- Discussion, Electronic Health Record Review and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2027to 2 Feb 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: Patients within 6 months of diagnosis of metastatic (or stage IV) solid malignancies
Who may be able to join
- Within 6 months of diagnosis of metastatic (or stage IV) solid malignancies
- Age 18 or greater
- English speaking
- Follow-up clinic visit (Supportive Care and Medical Oncology Outpatient Clinics at MD Anderson Cancer Center)
- Medical oncologist listed as the attending physician
- COHORT A (Oncology team only cohort): Patients should not have been referred to palliative care services at MD Anderson Cancer Center
- COHORT B (Oncology team and specialist palliative care cohort): Patients should have an upcoming specialist palliative care follow-up visit within 1 week of a medical oncology visit
Who cannot join
- Delirium (Memorial Delirium Assessment Scale [MDAS] >= 13/30)
- Significant hearing impairment requiring multiple repetitions during the screening process (that may prolong clinic time)
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
M D Anderson Cancer Center
Houston, Texas, 77030
David Hui, MD, 713-792-6258, dhui@mdanderson.org
David Hui, MD
About this study
Official title: Mapping the Processes of Cancer Care Delivery at a Comprehensive Cancer Center
This study examines how cancer care is delivered in oncology and supportive care clinics. Collecting patient feedback may help doctors better understand the processes of cancer care in oncology and supportive care clinics.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the total amount of follow-up clinic time spent on discussing supportive/palliative care issues between primary palliative care provided by the oncology team and specialist palliative care.
SECONDARY OBJECTIVES:
- To compare between the specialist palliative care team and the oncology team the following aspects of supportive/palliative care delivery: Ia. The number of supportive/palliative care needs the patient reported before the clinic visit (SPARC).
Ib. The number of supportive/palliative care needs the patient wanted to discuss with the clinical team before the clinic visit (SPARC).
Ic. The number of supportive/palliative care needs that were actually raised by the patient during the clinic visit (audiotape).
Id. The number of supportive/palliative care needs that were actually discussed by the clinical team during clinic visit (audiotape).
Ie. The number of supportive/palliative care needs that were documented in progress note by the clinical team after each visit (electronic health record).
If. The number of supportive/palliative care needs that the patient reported had been adequate addressed after the clinic visit (SPARC).
II. To compare the amount of clinic time (both absolute and proportion) spent on discussing supportive/palliative care issues by individual disciplines (e.g. medical doctor, registered nurse, counselor, pharmacist, psychologist, social worker, and priest) between the specialist palliative care team and the oncology team.
III. To examine the nature of topics discussed by the specialist palliative care team and the oncology team and compare the amount of clinic time (both absolute and proportion) spent on each supportive/palliative care issue.
IV. To compare the number of empathic statements between the specialist palliative care team and the oncology team.
- To compare the processes of supportive/palliative care delivery between patients seeing the oncology team without specialist palliative care (Cohort A) and patients seeing the oncology team when specialist palliative care team is involved (Cohort B).
OUTLINE:
Patients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team. Patients' medical records are also reviewed.
- Conditions
- Metastatic Malignant Solid Neoplasm
- Being tested
- Discussion, Electronic Health Record Review, 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.
DiscussionProcedure or surgery
Also called Discuss
Undergo audio recording of clinic conversations
Electronic Health Record ReviewOther
Review of medical records
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (questionnaire, clinic conversation) | Patients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team. Patients' medical records are also reviewed. Receives: Procedure: Discussion; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes spent in discussion
Will be examined using linear mixed models (LMMs) with physician as the unit of analysis.
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 posted27 Oct 2021
- Study start30 Jan 2027 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Solid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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
- David Hui, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095948
- Sponsor's protocol ID
- 2020-0246
- Other IDs
- NCI-2021-10266, 2020-0246
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Processes of Cancer Care Delivery at a Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT05095948
- Acronym / sponsor ID
- 2020-0246
- Conditions
- Metastatic Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 27 Oct 2021 (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 study examines how cancer care is delivered in oncology and supportive care clinics. Collecting patient feedback may help doctors better understand the processes of cancer care in oncology and supportive care clinics.
Detailed description
PRIMARY OBJECTIVES:
- To compare the total amount of follow-up clinic time spent on discussing supportive/palliative care issues between primary palliative care provided by the oncology team and specialist palliative care.
SECONDARY OBJECTIVES:
- To compare between the specialist palliative care team and the oncology team the following aspects of supportive/palliative care delivery: Ia. The number of supportive/palliative care needs the patient reported before the clinic visit (SPARC).
Ib. The number of supportive/palliative care needs the patient wanted to discuss with the clinical team before the clinic visit (SPARC).
Ic. The number of supportive/palliative care needs that were actually raised by the patient during the clinic visit (audiotape).
Id. The number of supportive/palliative care needs that were actually discussed by the clinical team during clinic visit (audiotape).
Ie. The number of supportive/palliative care needs that were documented in progress note by the clinical team after each visit (electronic health record).
If. The number of supportive/palliative care needs that the patient reported had been adequate addressed after the clinic visit (SPARC).
II. To compare the amount of clinic time (both absolute and proportion) spent on discussing supportive/palliative care issues by individual disciplines (e.g. medical doctor, registered nurse, counselor, pharmacist, psychologist, social worker, and priest) between the specialist palliative care team and the oncology team.
III. To examine the nature of topics discussed by the specialist palliative care team and the oncology team and compare the amount of clinic time (both absolute and proportion) spent on each supportive/palliative care issue.
IV. To compare the number of empathic statements between the specialist palliative care team and the oncology team.
- To compare the processes of supportive/palliative care delivery between patients seeing the oncology team without specialist palliative care (Cohort A) and patients seeing the oncology team when specialist palliative care team is involved (Cohort B).
OUTLINE:
Patients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team. Patients' medical records are also reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (questionnaire, clinic conversation) | – | Procedure: Discussion, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team. Patients' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within 6 months of diagnosis of metastatic (or stage IV) solid malignancies
Key inclusion criteria (7 listed)
- Within 6 months of diagnosis of metastatic (or stage IV) solid malignancies
- Age 18 or greater
- English speaking
- Follow-up clinic visit (Supportive Care and Medical Oncology Outpatient Clinics at MD Anderson Cancer Center)
- Medical oncologist listed as the attending physician
Key exclusion criteria (2 listed)
- Delirium (Memorial Delirium Assessment Scale [MDAS] >= 13/30)
- Significant hearing impairment requiring multiple repetitions during the screening process (that may prolong clinic time)
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 |
|---|---|---|
| DiscussionAlso: DiscussUndergo audio recording of clinic conversations | Procedure or surgery | Supportive Care (questionnaire, clinic conversation) |
| Electronic Health Record ReviewReview of medical records | Other | Supportive Care (questionnaire, clinic conversation) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive Care (questionnaire, clinic conversation) |
Primary outcome
Minutes spent in discussion
Time frame: through study completion, an average of 1 year
Will be examined using linear mixed models (LMMs) with physician as the unit of analysis.
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 11 Sep 2026.
- MD Anderson Cancer CenterLink 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.
David Hui 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?
An observational study of Metastatic Malignant Solid Neoplasm, 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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Sep 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 David Hui, MD ((713) 792-6258, dhui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes spent in discussion (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 11 Sep 2026.