Lung CancerNCT06420206
Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center
A study of Lung Cancer and Gastrointestinal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Gastrointestinal Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 2 Feb 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
- Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment
- Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available.
- Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status)
- Participant has the ability to speak and write in English
- Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent
Who cannot join
- Participant is already enrolled in hospice
- Participant is comatose
- Participant has severe intellectual disability
- Participant has a history of dementia documented in the medical records
- Participant has baseline communication barriers such as aphasia or deafness
- Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival
Show all 9Show fewer
- Participant is 18 years or older, currently cared for by pediatrics service
- Pregnant women
- Prisoners
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
MD Anderson Cancer Center
Houston, Texas, 77030
Ahmed Elsayem, MD,MPH, 713-745-9911, aelsayem@mdanderson.org
Ahmed Elsayem, MD,MPH
About this study
To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.
Read the detailed description
Primary Objective:
To compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ED), referred to as Acute Cancer Care Center (ACCC), visit for patients who receive the emergency department-based GOC intervention and those who do not.
Secondary Objective:
To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the GOC intervention in the ACCC and those who do not.
- Conditions
- Lung Cancer, Gastrointestinal Cancer
- Being tested
- Standard of Care (Acute Cancer Care Center), Standard of Care (Goals of Care)
- Medical subject headings
- Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (Acute Cancer Care Center)Other
In Group 1, participants will receive the usual standard of care by an emergency care physician not trained in palliative care.
Standard of Care (Goals of Care)Other
In Group 2, participants will receive standard of care plus palliative care intervention by an emergency care physician trained in palliative care.
| Study group | Role | What they receive |
|---|---|---|
| Acute Cancer Care Center | Other | In Group 1, participants will receive the usual standard of care, during your emergency room visit, provided by the Acute Cancer Care Center (ACCC) treating doctor who will address symptoms and other medical problems that brought the participant to the emergency room. Receives: Other: Standard of Care (Acute Cancer Care Center) |
| Goals of Care | Other | In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention. Receives: Other: Standard of Care (Goals of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life Questionnaire
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 posted17 May 2024
- Study start14 May 2024
- 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 Lung CancerStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Elsayem, MD,MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420206
- Sponsor's protocol ID
- 2019-1024
- Other IDs
- NCI-2024-04393
- Status last verified
- Jul 2026
- First submitted
- 14 May 2024
- Last updated
- 14 Jul 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT06420206
- Acronym / sponsor ID
- 2019-1024
- Conditions
- Lung Cancer, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 17 May 2024 (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 improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.
Detailed description
Primary Objective:
To compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ED), referred to as Acute Cancer Care Center (ACCC), visit for patients who receive the emergency department-based GOC intervention and those who do not.
Secondary Objective:
To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the GOC intervention in the ACCC and those who do not.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Cancer Care Center | Other | Other: Standard of Care (Acute Cancer Care Center)In Group 1, participants will receive the usual standard of care, during your emergency room visit, provided by the Acute Cancer Care Center (ACCC) treating doctor who will address symptoms and other medical problems that brought the participant to the emergency room. |
| Goals of Care | Other | Other: Standard of Care (Goals of Care)In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment
- Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available.
- Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status)
- Participant has the ability to speak and write in English
- Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent
Key exclusion criteria (9 listed)
- Participant is already enrolled in hospice
- Participant is comatose
- Participant has severe intellectual disability
- Participant has a history of dementia documented in the medical records
- Participant has baseline communication barriers such as aphasia or deafness
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 |
|---|---|---|
| Standard of Care (Acute Cancer Care Center)In Group 1, participants will receive the usual standard of care by an emergency care physician not trained in palliative care. | Other | Acute Cancer Care Center |
| Standard of Care (Goals of Care)In Group 2, participants will receive standard of care plus palliative care intervention by an emergency care physician trained in palliative care. | Other | Goals of Care |
Primary outcome
Quality Of Life Questionnaire
Time frame: through study completion; an average of 1 year
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 14 Jul 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.
Ahmed Elsayem, MD,MPH 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 of Lung Cancer and Gastrointestinal Cancer, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 Jul 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 Ahmed Elsayem, MD,MPH ((713) 745-9911, aelsayem@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life Questionnaire (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 14 Jul 2026.