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).
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.
Study Type
INTERVENTIONAL
Allocation
Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
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.
University of Alabama - Birmingham
Birmingham, Alabama, United States
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
Patient Quality of Life (QOL)
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia).
Time frame: Up to 2 Weeks
Patient Depression Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Time frame: Up to 12 Weeks
Patient Anxiety Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Time frame: Up to 12 Weeks
Patient Post-Traumatic Stress Disorder (PTSD) Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to post-traumatic stress (PTSD) symptoms as measured by the Post-Traumatic Stress Checklist-Civilian version. Higher scores on the Post-Traumatic Stress Checklist (range 17-85) indicate greater PTSD symptoms.
Time frame: Up to 12 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2,300
Stanford University
Stanford, California, United States
RECRUITINGUniversity of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Evanston, Illinois, United States
RECRUITINGIndiana University
Bloomington, Indiana, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITING...and 10 more locations
End-of-Life (EOL) Communication
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient reported end-of-life (EOL) communication measured by the Prognostic Awareness Impact Scale (PAIS). The PAIS includes an item that measures patient self-report of communication about their wishes if they were dying (yes vs. no).
Time frame: Up to 12 Weeks
End-of-Life (EOL) Care
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to chemotherapy administration in the last 30 days of life based on documentation from the Electronic Health Record.
Time frame: Last 30 days of life
Caregiver Quality of Life (QOL)
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver quality of life measured by the Caregiver Oncology QOL Questionnaire (CARGOQOL). Higher scores on CARGOQOL (range 0-100) indicate better QOL.
Time frame: Up to 12 Weeks
Caregiver Burden
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver burden measured by the Caregiver Reaction Assessment (CRA). Higher scores on the CRA (range 24-120) indicate greater caregiving burden.
Time frame: Up to 12 Weeks
Caregiver Depression Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS). Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.
Time frame: Up to 12 Weeks
Caregiver Anxiety Symptoms
Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS). Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Time frame: Up to 12 Weeks