Hematologic Diseases, Hematologic Malignancy, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myeloma
Conditions
Keywords
Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy, Hematologic Diseases, Lymphoma
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.
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.
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospice Enrollment Rate | 6 months | Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care. |
| Length of Hospice Enrollment | 6 months | Number of days from hospice enrollment to date of death or hospice disenrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive care unit (ICU) Admission Rate | Last 30 days of life | Compare ICU admission in the last 30 days of life between those with access to HEME-Hospice versus usual care |
| Hospital Death | Last 30 days of life | Compare occurrence of death in the hospital between those with access to HEME-Hospice versus usual care |
| High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life | Last 30 days of life | Compare the dollar amount of total expenditures between participants with access to HEME-Hospice versus usual care in the final 30 days of life. |
| Patient Quality of life | 6 months | Assess whether access to HEME-Hospice is superior to usual care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Pal version 4. Higher scores on the FACIT-Pal version 4 (range 0-184) indicate better QOL. |
| Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score | 6 months | Assessed by the FACT-Anemia version 4 subscale, a 20-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 80 with higher scores indicating better quality of life with respect to symptoms related to anemia and fatigue. |
| Chemotherapy Utilization in the Last 14 Days of Life | Last 14 days of life | Compare chemotherapy use in the last 14 days of life between those with access to HEME-Hospice versus usual care |
| Patient Anxiety Symptoms | 6 months | Compare anxiety symptoms between patients with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms. |
| Patient Depression Symptoms | 6 months | Compare depression symptoms between patients with access to HEME-Hospice versus usual care, using the Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms. |
| Caregiver Quality of Life | 6 months | Assess whether access to HEME-Hospice is superior to usual care with respect to caregiver-reported quality of life (QOL) as measured by the Caregiver Oncology QOL questionnaire. Higher scores on Caregiver Oncology QOL instrument (range 0-100) indicate better QOL. |
| Caregiver Anxiety Symptoms | 6 months | Compare anxiety symptoms between caregivers with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms. |
| Caregiver Depression Symptoms | 6 months | Compare depression symptoms between caregivers with access to HEME-Hospice versus usual care, using the depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms. |
| Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score | 6 months | Assessed by the FACT-Thrombocytopenia version 4 subscale, a 6-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 24 with higher scores indicating better quality of life with respect to thrombocytopenia-related symptoms. |
| Hospitalization Rate | Last 30 days of life | Compare hospitalization (2 or more hospitalizations) in the last 30 days of life between those with access to HEME-Hospice versus usual care |
Countries
United States
Contacts
Primary ContactOreofe Odejide, MD, MPH
Backup ContactSunny Rosenthal, MPH
Outcome results
None listed