HEME Home Transfusion Program

NCT ID: NCT06487247

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2029-05-31

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.

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.

Conditions

Leukemia; Myeloma; Myelodysplastic Syndromes; Hematologic Malignancy; Hematologic Diseases; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HEME-Hospice Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HEME-Hospice

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Oreofe Odejide, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oreofe Odejide, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oreofe Odejide, MD, MPH

Role: CONTACT

Oreofe_Odejide@dfci.harvard.edu

617-632-6864

Sunny Rosenthal, MPH

Role: CONTACT

sjrosenthal@mgb.org

857-215-2820

Facility Contacts

Oreofe Odejide, MD, MPH

Role: primary

Oreofe_Odejide@dfci.harvard.edu

617-632-6864

Oreofe Odejide, MD, MPH

Role: primary

Oreofe_Odejide@dfci.harvard.edu

617-632-6864

Other Identifiers

1R37CA289639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-040

Identifier Type: -

Identifier Source: org_study_id