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

NCT ID: NCT06420206

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2027-02-02

Brief Summary

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

Detailed Description

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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

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Lung Cancer Gastrointestinal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Standard of Care (Acute Cancer Care Center)

Intervention Type OTHER

In Group 1, participants will receive the usual standard of care by an emergency care physician not trained in palliative care.

Goals of Care

In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention.

Group Type OTHER

Standard of Care (Goals of Care)

Intervention Type OTHER

In Group 2, participants will receive standard of care plus palliative care intervention by an emergency care physician trained in palliative care.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Elsayem, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ahmed Elsayem, MD,MPH

Role: CONTACT

Phone: (713) 745-9911

Email: [email protected]

Facility Contacts

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Ahmed Elsayem, MD,MPH

Role: primary

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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2019-1024

Identifier Type: -

Identifier Source: org_study_id