Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- Hospice Enrollment Rate
研究概览
简要总结
This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.
详细描述
Lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. Transfusions palliate these symptoms and improve quality of life (QOL); yet, most hospices do not provide access to transfusions. Patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. Patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care.
The study team has thus developed a new model of care (HEME-Hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life (QOL), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as QOL and mood of their caregivers. This study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to HEME-Hospice versus usual care. Participants in this study will have access to HEME-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hospice Enrollment Rate
时间窗: 6 months
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Length of Hospice Enrollment
时间窗: 6 months
Number of days from hospice enrollment to date of death or hospice disenrollment
次要结局
- Hospitalization Rate(Last 30 days of life)
- Chemotherapy Utilization in the Last 14 Days of Life(Last 14 days of life)
- Caregiver Quality of Life(6 months)
- Intensive care unit (ICU) Admission Rate(Last 30 days of life)
- Hospital Death(Last 30 days of life)
- High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life(Last 30 days of life)
- Patient Anxiety Symptoms(6 months)
- Caregiver Anxiety Symptoms(6 months)
- Caregiver Depression Symptoms(6 months)
- Patient Quality of life(6 months)
- Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score(6 months)
- Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score(6 months)
- Patient Depression Symptoms(6 months)
研究者
Oreofe Odejide, MD
Principal Investigator
Dana-Farber Cancer Institute
