跳至主要内容
临床试验/NCT06487247
NCT06487247招募中不适用

Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial

Dana-Farber Cancer Institute4 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2025年9月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oreofe Odejide, MD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (4)

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