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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06420206
Other study ID # 2019-1024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 14, 2024
Est. completion date February 2, 2027

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Ahmed Elsayem, MD,MPH
Phone (713) 745-9911
Email aelsayem@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality Of Life Questionnaire through study completion; an average of 1 year
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