HEME Home Transfusion Program
Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
2 other identifiers
interventional
700
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable leukemia
Started Sep 2025
Typical duration for not_applicable leukemia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedStudy Start
First participant enrolled
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
September 17, 2025
September 1, 2025
3.7 years
June 27, 2024
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospice Enrollment Rate
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
6 months
Length of Hospice Enrollment
Number of days from hospice enrollment to date of death or hospice disenrollment
6 months
Secondary Outcomes (13)
Chemotherapy Utilization in the Last 14 Days of Life
Last 14 days of life
Hospitalization Rate
Last 30 days of life
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
- +8 more secondary outcomes
Study Arms (2)
Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care)
EXPERIMENTALParticipants assigned to access to HEME-Hospice care who enroll in hospice will have at least once weekly assessment of symptoms of anemia and thrombocytopenia by the study team and will receive transfusions at home as indicated. Individualized care appointments with hospice care team providers, and frequency of visits are determined by individual participant need.
Arm 2: Usual Care
NO INTERVENTIONParticipants assigned to usual care will receive standard oncology care delivered by the hematologic oncologists. Participants will have access to regular/standard hospice care if they elect to enroll in hospice.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- Identified informal caregiver of enrolled patient with hematologic malignancy
- Age ≥ 18 years
You may not qualify if:
- Age \< 18 years
- Already enrolled in hospice
- Resides in nursing home or assisted living facility
- History of previous serious adverse transfusion reaction
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oreofe Odejide, MD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 5, 2024
Study Start
September 10, 2025
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.