Recruiting

HEME-Hospice

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06487247

Conditions

Leukemia

Myeloma

Myelodysplastic Syndromes

Hematologic Malignancy

Hematologic Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HEME-Hospice Program

Study Details

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.

Conditions

Leukemia

Myeloma

Myelodysplastic Syndromes

Hematologic Malignancy

Hematologic Diseases

Study ID

NCT06487247

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Hospice Enrollment Rate [ Time Frame: 6 months ]
  • Length of Hospice Enrollment [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Oreofe Odejide, MD, MPH

617-632-6864Oreofe_Odejide@dfci.harvard.edu

Sunny Rosenthal, MPH

857-215-2820sjrosenthal@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Oreofe Odejide, MD, MPH

617-632-6864Oreofe_Odejide@dfci.harvard.edu

Principal Investigator:

Oreofe Odejide, MD, MPH

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Oreofe Odejide, MD, MPH

617-632-6864Oreofe_Odejide@dfci.harvard.edu

Principal Investigator:

Oreofe O. Odejide, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-09-17.