About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient Inclusion Criteria
Patients with new diagnosis ≥ 60 years of age
An antecedent hematologic disorder
Therapy related-disease
Disqualifiers
Patients with a diagnosis of acute promyelocytic leukemia (APML)
Patients with AML receiving supportive care alone
Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures
Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment
Trial design
Parallel
Treatments tested in this trial
Specialty Palliative Care
BehavioralParticipants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.
Primary Palliative Care
BehavioralParticipants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
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.
Other outcomes
Patient Prognostic Understanding
Compare patient prognostic understanding between those receiving primary palliative care and specialty palliative care based on the Prognostic Awareness Impact Scale (PAIS). The PAIS items that focus on the likelihood of cure will be used to compare prognostic understanding. Patients will report the likelihood of cure of their leukemia on a Likert's scale. Prognostic understanding will be dichotomized into likely cure versus. unlikely cure and compared between the two groups.
Patient Coping
Compare patient coping between those receiving primary palliative care versus specialty palliative care using the Brief Cope. Higher scores on the domains of the Brief Cope indicate higher use of coping strategies.
Hospitalization
Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.
Intensive Care Unit (ICU) Admissions
Compare intensive care unit admissions in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator