This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML and MDS undergoing treatment. The investigators aim to find out whether introducing patients and families undergoing AML and MDS treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
Massachusetts general Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Time frame: 2 weeks
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Time frame: up to 6 months
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.
Time frame: up to 6 months
Compare Symptom Burden (as per ESAS) Between Study Arms.
We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.
Time frame: up to 6 months
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms
Time frame: up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
We will compare patient-reported discussing their EOL care preferences between the two groups
Time frame: up to 6 months
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
to compare rates of chemotherapy administration near the end of life between the two arms
Time frame: up to 6 months
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
to compare rates of hospitalizations within the last week of life between the study arms
Time frame: up to 6 months
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
Time frame: up to 6 months