HEME Home Transfusion Program

Trial Title: HEME Home Transfusion Program

NCT ID: NCT06487247

Condition: Leukemia
Myeloma
Myelodysplastic Syndromes
Hematologic Malignancy
Hematologic Diseases
Lymphoma

Conditions: Official terms:
Neoplasms
Preleukemia
Hematologic Neoplasms
Myelodysplastic Syndromes
Hematologic Diseases

Conditions: Keywords:
Leukemia
Myeloma
Myelodysplastic Syndromes
Hematologic Malignancy
Hematologic Diseases
Lymphoma

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: HEME-Hospice Program
Description: 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 group label: Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care)

Other name: HEME-Hospice

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Brigham and Women's Hospital

Address:
City: Boston
Zip: 02215
Country: United States

Contact:
Last name: Oreofe Odejide, MD, MPH

Phone: 617-632-6864
Email: Oreofe_Odejide@dfci.harvard.edu

Investigator:
Last name: Oreofe Odejide, MD, MPH
Email: Principal Investigator

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Contact:
Last name: Oreofe Odejide, MD, MPH

Phone: 617-632-6864
Email: Oreofe_Odejide@dfci.harvard.edu

Investigator:
Last name: Oreofe O. Odejide, MD
Email: Principal Investigator

Start date: November 2024

Completion date: May 31, 2029

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06487247