Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Time from documentation of end-of-life care preferences to death
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Collaborative palliative and oncology care
- 1st palliative care visit within 30 days of randomization in the outpatient or hospital
- In outpatient setting: once monthly palliative care visits (or video/ or phone)
- During hospital admissions: At least twice weekly palliative care visits
干预措施: Palliative Care (Other)
Collaborative palliative and oncology care
- 1st palliative care visit within 30 days of randomization in the outpatient or hospital
- In outpatient setting: once monthly palliative care visits (or video/ or phone)
- During hospital admissions: At least twice weekly palliative care visits
干预措施: Standard Leukemia care (Other)
Standard oncology care
- Palliative care consults only upon request
- Standard oncology care
干预措施: Standard Leukemia care (Other)
结局指标
主要结局
Time from documentation of end-of-life care preferences to death
时间窗: up to 2 years
comparison of time from documentation of end-of-life care preferences to death in the electronic health records
次要结局
- Rates of documentation of end-of-life care preferences at least one week prior to death.(up to 2 years)
- Rate of hospice utilization and length-of-stay in hospice(up to 2 years)
- compare quality of life(up to six months)
- compare mood(up to six months)
- 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)
- compare symptom burden(up to six months)
- Compare Rate of hospitalization between the study arms(up to 30 days)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital