HEME Home Transfusion Program

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Myelodysplastic Syndromes; Hematologic Diseases; Leukemia; Hematologic Malignancy; Myeloma
• Intervention / Treatment: Behavioral: HEME-Hospice Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oreofe Odejide, MD, MPH; Phone Number: 617-632-6864; Email: Oreofe_Odejide@dfci.harvard.edu
• Study Contact Backup: Name: Sunny Rosenthal, MPH; Phone Number: 857-215-2820; Email: sjrosenthal@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Oreofe O. Odejide, MD
      • Contact: Oreofe Odejide, MD, MPH; Phone Number: 617-632-6864; Email: Oreofe_Odejide@dfci.harvard.edu
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Oreofe Odejide, MD, MPH; Phone Number: 617-632-6864; Email: Oreofe_Odejide@dfci.harvard.edu
      • Principal Investigator: Oreofe Odejide, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care); Participants 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.	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.; Other Names: HEME-Hospice
No Intervention: Arm 2: Usual Care; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy Utilization in the Last 14 Days of Life	Compare chemotherapy use in the last 14 days of life between those with access to HEME-Hospice versus usual care	Last 14 days of life
Hospitalization Rate	Compare hospitalization (2 or more hospitalizations) in the last 30 days of life between those with access to HEME-Hospice versus usual care	Last 30 days of life
Intensive care unit (ICU) Admission Rate	Compare ICU admission in the last 30 days of life between those with access to HEME-Hospice versus usual care	Last 30 days of life
Hospital Death	Compare occurrence of death in the hospital between those with access to HEME-Hospice versus usual care	Last 30 days of life
High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life	Compare the dollar amount of total expenditures between participants with access to HEME-Hospice versus usual care in the final 30 days of life.	Last 30 days of life
Patient Quality of life	Assess whether access to HEME-Hospice is superior to usual care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Pal version 4. Higher scores on the FACIT-Pal version 4 (range 0-184) indicate better QOL.	6 months
Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score	Assessed by the FACT-Anemia version 4 subscale, a 20-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 80 with higher scores indicating better quality of life with respect to symptoms related to anemia and fatigue.	6 months
Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score	Assessed by the FACT-Thrombocytopenia version 4 subscale, a 6-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 24 with higher scores indicating better quality of life with respect to thrombocytopenia-related symptoms.	6 months
Patient Anxiety Symptoms	Compare anxiety symptoms between patients with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.	6 months
Patient Depression Symptoms	Compare depression symptoms between patients with access to HEME-Hospice versus usual care, using the Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms.	6 months
Caregiver Quality of Life	Assess whether access to HEME-Hospice is superior to usual care with respect to caregiver-reported quality of life (QOL) as measured by the Caregiver Oncology QOL questionnaire. Higher scores on Caregiver Oncology QOL instrument (range 0-100) indicate better QOL.	6 months
Caregiver Anxiety Symptoms	Compare anxiety symptoms between caregivers with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.	6 months
Caregiver Depression Symptoms	Compare depression symptoms between caregivers with access to HEME-Hospice versus usual care, using the depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms.	6 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Oreofe Odejide, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Lymphoma; Leukemia; Hematologic Diseases; Myelodysplastic Syndromes; Myeloma; Hematologic Malignancy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Leukemia; Hematologic Neoplasms; Lymphoma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Hematologic Diseases
• Other Study ID Numbers: 24-040; 1R37CA289639 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No