Acute Myeloid Leukemia Clinical Trial
Official title:
Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Verified date | February 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Hospitalized patients with high-risk AML, defined as: - Newly diagnosed patients with AML = 60 years of age - Newly diagnosed AML with antecedent hematologic disorder - Newly diagnosed therapy-related AML - Relapsed AML - Primary refractory AML Exclusion Criteria: - Patients already receiving palliative care - Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures. - A diagnosis of acute promyelocytic leukemia (APML) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts general Hospital | Boston | Massachusetts |
United States | Ohio State University | Columbus | Ohio |
United States | Duke University | Durham | North Carolina |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 weeks | |
Secondary | 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. | up to 6 months | |
Secondary | 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. | up to 6 months | |
Secondary | 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. | up to 6 months | |
Secondary | 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 | up to 6 months | |
Secondary | 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 | up to 6 months | |
Secondary | 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 | up to 6 months | |
Secondary | 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 | up to 6 months | |
Secondary | 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 | up to 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
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