Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center

To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Other: Standard of Care (Acute Cancer Care Center); Other: Standard of Care (Goals 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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elsayem, MD,MPH; Phone Number: (713) 745-9911; Email: aelsayem@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Ahmed Elsayem, MD,MPH; Phone Number: 713-745-9911; Email: aelsayem@mdanderson.org
      • Principal Investigator: Ahmed Elsayem, MD,MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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: Goals of Care; In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality Of Life Questionnaire	through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Ahmed Elsayem, MD,MPH, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Patient Care Management; Comprehensive Health Care; Standard of Care; Patient Care Planning
• Other Study ID Numbers: 2019-1024; NCI-2024-04393 (Other Identifier: Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No