Clinical trial NCT06487247: HEME Home Transfusion Program
Official title: Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leukemia
Myeloma
Myelodysplastic Syndromes
Hematologic Malignancy
Hematologic Diseases
Lymphoma
Keywords: Leukemia
Myeloma
Myelodysplastic Syndromes
Hematologic Malignancy
Hematologic Diseases
Lymphoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-05
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hospice Enrollment Rate
timeFrame: 6 months
measure: Length of Hospice Enrollment
timeFrame: 6 months
Secondary outcomes:
measure: Chemotherapy Utilization in the Last 14 Days of Life
timeFrame: Last 14 days of life
measure: Hospitalization Rate
timeFrame: Last 30 days of life
measure: Intensive care unit (ICU) Admission Rate
timeFrame: Last 30 days of life
measure: Hospital Death
timeFrame: Last 30 days of life
measure: High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life
timeFrame: Last 30 days of life
measure: Patient Quality of life
timeFrame: 6 months
measure: Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
timeFrame: 6 months
measure: Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score
timeFrame: 6 months
measure: Patient Anxiety Symptoms
timeFrame: 6 months
measure: Patient Depression Symptoms
timeFrame: 6 months
measure: Caregiver Quality of Life
timeFrame: 6 months
measure: Caregiver Anxiety Symptoms
timeFrame: 6 months
measure: Caregiver Depression Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Oreofe Odejide, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: