A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 undergoing treatment. The investigators aim to find out whether introducing patients and families undergoing AML 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.

Official Title
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Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: Standard Leukemia Care
* Other: Palliative Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Leukemia Care<br>Standard Leukemia care | Other: Standard Leukemia Care<br> <br> |
| Experimental: Collaborative Palliative and Oncology Care<br>Collaborative care from Palliative Care and Leukemia will be given | Other: Palliative Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Acute Myeloid Leukemia