Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Summary
This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
Detailed description
Patients with newly diagnosed AML confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent hospitalization to begin therapy. During their hospitalization for chemotherapy, patients with AML often experience difficult physical symptoms that negatively impact their quality of life and physical function. Patients with AML also experience significant psychological distress as they combat the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence. The abrupt onset of these symptoms can be distressing to both the patient and their family and friends (also called "caregivers"). Research has shown that early involvement of a team of clinicians specializing in lessening (or "palliating") these physical and emotional symptoms and helping patients and their caregivers cope with AML improves their quality of life and experience with their illness. This team is called "specialty palliative care" and consists of physicians and advanced practice providers who work closely and collaboratively with the oncology team to care for patients and caregivers. Research has also shown that training oncology clinicians to incorporate palliative care skills into their practice, called "primary palliative care," is an alternative strategy to having specialty palliative care clinicians care for patients with leukemia. The purpose of this study is to determine whether specialty palliative care or primary palliative care is the best way to improve the quality of life and experience of patients with AML and their caregivers. This study will randomly assign hospitals to deliver either specialty palliative care or primary palliative care for patients with AML. Participants in this study will receive either specialty or primary palliative care during their hospital stays based upon which strategy their hospital has been assigned to. Participants assigned to specialty palliative care will be care for by both oncology and palliative care clinicians during their hospital stays for AML. Participants assigned to primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during their hospital stays for AML.
Arms & interventions
- BehavioralSpecialty Palliative Care
Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
- BehavioralPrimary Palliative Care
Participants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.
Outcome measures
Primary
Quality of Life (QOL)
Establish that primary palliative care is non-inferior to specialty palliative care in patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 12 weeks. Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.
Time frame: Over 12 weeks
Secondary
Patient Quality of Life (QOL)
Time frame: Up to 2 Weeks
Patient Depression Symptoms
Time frame: Up to 12 Weeks
Patient Anxiety Symptoms
Time frame: Up to 12 Weeks
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms
Time frame: Up to 12 Weeks
End-of-Life (EOL) Communication
Time frame: Up to 12 Weeks
End-of-Life (EOL) Care
Time frame: Last 30 days of life
Caregiver Quality of Life (QOL)
Time frame: Up to 12 Weeks
Caregiver Burden
Time frame: Up to 12 Weeks
Caregiver Depression Symptoms
Time frame: Up to 12 Weeks
Caregiver Anxiety Symptoms
Time frame: Up to 12 Weeks
Eligibility criteria
Study locations (20)
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Stanford University
Stanford, California, 94305
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, 80204
University of Miami
Miami, Florida, 33146
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University
Atlanta, Georgia, 30322
Northwestern University
Evanston, Illinois, 60208
Indiana University
Bloomington, Indiana, 47405
Johns Hopkins University
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14627
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27708
Ohio State University
Columbus, Ohio, 43210
Oregon Health & Science University
Portland, Oregon, 97239
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Wisconsin
Madison, Wisconsin, 53715