Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 700
- Locations
- 2
- Primary Endpoint
- Hospice Enrollment Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy 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
Arms & Interventions
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.
Intervention: HEME-Hospice Program (Behavioral)
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.
Outcomes
Primary Outcomes
Hospice Enrollment Rate
Time Frame: 6 months
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Length of Hospice Enrollment
Time Frame: 6 months
Number of days from hospice enrollment to date of death or hospice disenrollment
Secondary Outcomes
- Hospitalization Rate(Last 30 days of life)
- Chemotherapy Utilization in the Last 14 Days of Life(Last 14 days of life)
- Caregiver Quality of Life(6 months)
- Caregiver Depression Symptoms(6 months)
- Intensive care unit (ICU) Admission Rate(Last 30 days of life)
- Hospital Death(Last 30 days of life)
- High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life(Last 30 days of life)
- Patient Anxiety Symptoms(6 months)
- Caregiver Anxiety Symptoms(6 months)
- Patient Quality of life(6 months)
- Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score(6 months)
- Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score(6 months)
- Patient Depression Symptoms(6 months)
Investigators
Oreofe Odejide, MD
Principal Investigator
Dana-Farber Cancer Institute