HEME Home Transfusion Program
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: HEME-Hospice Program.
- Кому может быть актуально
- Состояния в реестре: Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое HEME-Hospice Program
A care delivery program that combines home-based transfusions with routine home hospice care. Transfusions are administered by trained transfusion nurses. Standard hospice care is provided by an interdisciplinary team of non-transfusion nurse case managers, hospice aides, social workers, and chaplains.
Первичные конечные точки
- Hospice Enrollment Rate [Срок оценки: 6 months]
- Length of Hospice Enrollment [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Chemotherapy Utilization in the Last 14 Days of Life [Срок оценки: Last 14 days of life]
- Hospitalization Rate [Срок оценки: Last 30 days of life]
- Intensive care unit (ICU) Admission Rate [Срок оценки: Last 30 days of life]
- Hospital Death [Срок оценки: Last 30 days of life]
- High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life [Срок оценки: Last 30 days of life]
- Patient Quality of life [Срок оценки: 6 months]
- Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score [Срок оценки: 6 months]
- Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score [Срок оценки: 6 months]
- Patient Anxiety Symptoms [Срок оценки: 6 months]
- Patient Depression Symptoms [Срок оценки: 6 months]
- Caregiver Quality of Life [Срок оценки: 6 months]
- Caregiver Anxiety Symptoms [Срок оценки: 6 months]
Критерии участия
Inclusion Criteria for Patient Participants:
- Diagnosis of a relapsed/refractory hematologic malignancy
- Age ≥ 18 years
- Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
- Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a severe transfusion reaction
- Patient resides within catchment served by Care Dimensions Hospice
- Physician-estimated prognosis of six months or less
Inclusion Criteria for Caregivers:
- Identified informal caregiver of enrolled patient with hematologic malignancy
- Age ≥ 18 years
Exclusion Criteria for Patient Participants:
- Age < 18 years
- Already enrolled in hospice
- Resides in nursing home or assisted living facility
- History of previous serious adverse transfusion reaction
Exclusion Criteria for Caregivers:
-Age < 18 years
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Brigham and Women's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Идентификаторы
NCT: NCT06487247 · 24-040 · 1R37CA289639