HEME Home Transfusion Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEME-Hospice Program.
- Who it may be relevant to
- Registry conditions: Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Hospice Enrollment Rate [Time frame: 6 months]
- Length of Hospice Enrollment [Time frame: 6 months]
Secondary outcome measures (12)
- Chemotherapy Utilization in the Last 14 Days of Life [Time frame: Last 14 days of life]
- Hospitalization Rate [Time frame: Last 30 days of life]
- Intensive care unit (ICU) Admission Rate [Time frame: Last 30 days of life]
- Hospital Death [Time frame: Last 30 days of life]
- High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life [Time frame: Last 30 days of life]
- Patient Quality of life [Time frame: 6 months]
- Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score [Time frame: 6 months]
- Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score [Time frame: 6 months]
- Patient Anxiety Symptoms [Time frame: 6 months]
- Patient Depression Symptoms [Time frame: 6 months]
- Caregiver Quality of Life [Time frame: 6 months]
- Caregiver Anxiety Symptoms [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06487247 · 24-040 · 1R37CA289639