NCT Number: NCT06487247
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brigham and Women's Hospital, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patient Participants:
Inclusion criteria
for Caregivers:
Exclusion criteria
for Patient Participants:
Exclusion criteria
for Caregivers:
-Age < 18 years
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.
Other names: HEME-Hospice
Time frame: 6 months
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Time frame: 6 months
Number of days from hospice enrollment to date of death or hospice disenrollment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Last 30 days of life
Compare occurrence of death in the hospital between those with access to HEME-Hospice versus usual care
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Oreofe Odejide, MD, MPH
CONTACT
Sunny Rosenthal, MPH
CONTACT
Dana-Farber Cancer Institute
Other
Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
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