Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
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 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.
详细描述
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.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients already receiving palliative care
- •Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
- •A diagnosis of acute promyelocytic leukemia (APML)
研究组 & 干预措施
Standard Leukemia Care
Standard Leukemia care
干预措施: Standard Leukemia Care (Other)
Collaborative Palliative and Oncology Care
Collaborative care from Palliative Care and Leukemia will be given
干预措施: Palliative Care (Other)
结局指标
主要结局
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
时间窗: 2 weeks
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.
次要结局
- Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms(up to 6 months)
- Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms(up to 6 months)
- Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms(up to 6 months)
- Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.(up to 6 months)
- Compare Symptom Burden (as per ESAS) Between Study Arms.(up to 6 months)
- Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms(up to 6 months)
- Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms(up to 6 months)
- Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.(up to 6 months)
研究者
El-Jawahri, Areej,M.D.
MD
Massachusetts General Hospital