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

NCT ID: NCT06487247Sponsor: Dana-Farber Cancer InstituteLast updated: 2025-09-17

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.

Arms & interventions

  • BehavioralHEME-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.

Outcome measures

Primary

  • Hospice Enrollment Rate

    Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.

    Time frame: 6 months

  • Length of Hospice Enrollment

    Number of days from hospice enrollment to date of death or hospice disenrollment

    Time frame: 6 months

Secondary

  • Chemotherapy Utilization in the Last 14 Days of Life

    Time frame: Last 14 days of life

  • Hospitalization Rate

    Time frame: Last 30 days of life

  • Intensive care unit (ICU) Admission Rate

    Time frame: Last 30 days of life

  • Hospital Death

    Time frame: Last 30 days of life

  • High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life

    Time frame: Last 30 days of life

  • Patient Quality of life

    Time frame: 6 months

  • Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score

    Time frame: 6 months

  • Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score

    Time frame: 6 months

  • Patient Anxiety Symptoms

    Time frame: 6 months

  • Patient Depression Symptoms

    Time frame: 6 months

  • Caregiver Quality of Life

    Time frame: 6 months

  • Caregiver Anxiety Symptoms

    Time frame: 6 months

  • Caregiver Depression Symptoms

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

Recruiting
Oreofe Odejide, MD, MPH · Contact
Oreofe Odejide, MD, MPH · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Oreofe Odejide, MD, MPH · Contact
Oreofe O. Odejide, MD · Principal Investigator