Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
AML, MDS, Palliative care
Brief summary
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) and myelodysplastic syndrome (MDS) receiving non-intensive therapy
Detailed description
Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS 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 oncology care and standard oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with AML and MDS undergoing treatment. The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS 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.
Interventions
OTHERPalliative Care
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
Standard care per the hospital guideline
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from documentation of end-of-life care preferences to death | up to 2 years | comparison of time from documentation of end-of-life care preferences to death in the electronic health records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of documentation of end-of-life care preferences at least one week prior to death. | up to 2 years | Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record |
| Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire | up to 2 years | comparison of patient-report of discussion end-of-life care preferences between the study arms |
| Compare Rate of hospitalization between the study arms | up to 30 days | Compare rates of hospitalizations within 30 days of death between the study arms |
| Rate of hospice utilization and length-of-stay in hospice | up to 2 years | Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms |
| compare quality of life | up to six months | Compare quality of life (FACT-Leuk) at week-12 and longitudinally between the study arms. Score range 0-176 (higher scores indicating better quality of life) |
| compare symptom burden | up to six months | Compare symptom burden (ESAS) at week-12 and longitudinally between the study arms. the ESAS score range 0-100 with higher scores indicating worse symptom burden. |
| compare mood | up to six months | Compare change in mood (HADS) at week-12, and longitudinally between the study arms. HADS measures depression and anxiety symptoms (subscale range 0-21) higher scores indicating worse mood symptoms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAreej El-Jawahri, MD
Massachusetts General Hospital
Outcome results
None listed