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HEME Home Transfusion Program

NCT06487247 · Dana-Farber Cancer Institute
In plain English

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Official title
Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
About this study
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.
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
Study design
Enrollment target: 700 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-10
Estimated completion: 2029-05-31
Last updated: 2025-09-17
Interventions
Behavioral: HEME-Hospice Program
Primary outcomes
  • Hospice Enrollment Rate (6 months)
  • Length of Hospice Enrollment (6 months)
Sponsor
Dana-Farber Cancer Institute · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactOreofe Odejide, MD, MPH · contact · Oreofe_Odejide@dfci.harvard.edu · 617-632-6864
ContactSunny Rosenthal, MPH · contact · sjrosenthal@mgb.org · 857-215-2820
InvestigatorOreofe Odejide, MD, MPH · principal_investigator, Dana-Farber Cancer Institute
All locations (2)
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
HEME Home Transfusion Program · TrialPath