## Protocol Section
### Identification Module
**NCT ID:** NCT06420206

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

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

#### Organization Study ID Info
**ID:** 2019-1024
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
### Status Module
#### Completion Date
**Date:** 2027-02-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-02-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Lung Cancer

- Gastrointestinal Cancer

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Standard of Care (Acute Cancer Care Center)

**Label:** Acute Cancer Care Center

**Type:** OTHER

#### Arm Group 2

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

**Intervention Names:**

- Other: Standard of Care (Goals of Care)

**Label:** Goals of Care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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.

**Name:** Standard of Care (Acute Cancer Care Center)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- 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.

**Name:** Standard of Care (Goals of Care)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Quality Of Life Questionnaire

**Time Frame:** through study completion; an average of 1 year

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aelsayem@mdanderson.org

**Name:** Ahmed Elsayem, MD,MPH

**Phone:** (713) 745-9911

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** aelsayem@mdanderson.org

- **Name:** Ahmed Elsayem, MD,MPH

- **Phone:** 713-745-9911

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ahmed Elsayem, MD,MPH

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Ahmed Elsayem, MD,MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** MD Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: HIGH

- As Found: Gastrointestinal Cancer

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-31
