A Collaborative Palliative and Leukemia Care Model for Patients With AML Receiving Non-Intensive Therapy

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 end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) receiving non-intensive therapy

Detailed Description
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Frequently people undergoing leukemia treatment experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with acute leukemia receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia. This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing 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 with acute myeloid leukemia (AML) undergoing treatment. The purpose of this research study is to find out whether introducing patients undergoing treatment for acute myeloid leukemia to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.

Official Title
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Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With Acute Myeloid Leukemia Receiving Non-Intensive Therapy

Conditions
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Acute Myeloid Leukemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations: Newly diagnosed AML Relapsed AML Primary refractory AML The ability to provide informed consent The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter Exclusion Criteria: Patients not receiving care at MGH Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization) Patients receiving supportive care alone Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures Patients already receiving palliative care

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Collaborative palliative and oncology care<br>1st palliative care visit within 96 hours of randomization in the outpatient or hospital In outpatient setting: At least once weekly for the first 30 days and then at least twice per month thereafter palliative care clinic visits or contact via telephone During hospital admissions to MGH: At least twice weekly palliative care visits | Other: Palliative Care<br>* Specialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family<br>Other: Standard Leukemia care<br>* Standard care per the hospital guideline<br>|
| Active Comparator: Standard leukemia care<br>Palliative care consults only upon request Standard Leukemia care | Other: Standard Leukemia care<br>* Standard care per the hospital guideline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from documentation of end-of-life care preferences to death | comparison of time from documentation of end-of-life care preferences to death in the electronic health records | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of documentation of end-of-life care preferences at least one week prior to death. | Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record | 2 years | 
| Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire | comparison of patient-report of discussion end-of-life care preferences between the study arms | 2 years | 
| Compare Rate of hospitalization between the study arms | Compare rates of hospitalizations within 3, 7, 14, and 30 days of death between the study arms | up to 30 days | 
| Rate of hospice utilization and length-of-stay in hospice | Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms | 2 years | 
| compare changes in quality of life | Compare change in quality of life (FACT-Leuk) from baseline to week-2, week-4, and longitudinally between the study arms | up to one year | 
| Compare quality of end-of-life care between the two study arms | compare quality of end-of-life care (FAMCARE) as reported by caregivers between the two study arms | 2 years | 
| compare changes in symptom burden | Compare change in symptom burden (ESAS) from baseline to week-2, week-4, and longitudinally between the study arms | up to 2 years | 
| compare changes in mood | Compare change in mood (HADS) from baseline to week-2, week-4, and longitudinally between the study arms | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML