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Trial Title:
Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center
NCT ID:
NCT06420206
Condition:
Lung Cancer
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Standard of Care (Acute Cancer Care Center)
Description:
In Group 1, participants will receive the usual standard of care by an emergency care
physician not trained in palliative care.
Arm group label:
Acute Cancer Care Center
Intervention type:
Other
Intervention name:
Standard of Care (Goals of Care)
Description:
In Group 2, participants will receive standard of care plus palliative care intervention
by an emergency care physician trained in palliative care.
Arm group label:
Goals of Care
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participant is at least 18 years old presenting to the triage area of the MDACC ACCC
for treatment
2. Participant has advanced lung or GI cancer. Advanced cancer patient defined as:
locally recurrent or metastatic for which there is no curative treatment available.
3. Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea,
altered mental status, or poor performance status)
4. Participant has the ability to speak and write in English
5. Participant has the ability to provide consent OR is accompanied by a LAR able to
provide consent
Exclusion Criteria:
1. Participant is already enrolled in hospice
2. Participant is comatose
3. Participant has severe intellectual disability
4. Participant has a history of dementia documented in the medical records
5. Participant has baseline communication barriers such as aphasia or deafness
6. Participant is new to MDACC, without established oncology care at our institution at
time of ACCC arrival
7. Participant is 18 years or older, currently cared for by pediatrics service
8. Pregnant women
9. Prisoners
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ahmed Elsayem, MD,MPH
Phone:
713-745-9911
Email:
aelsayem@mdanderson.org
Investigator:
Last name:
Ahmed Elsayem, MD,MPH
Email:
Principal Investigator
Start date:
May 14, 2024
Completion date:
February 2, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06420206
http://www.mdanderson.org
