HEME Home Transfusion Program
- Conditions
- MyelomaLeukemiaMyelodysplastic SyndromesHematologic DiseasesHematologic MalignancyLymphoma
- Interventions
- Behavioral: HEME-Hospice Program
- Registration Number
- NCT06487247
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care) HEME-Hospice Program 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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.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 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.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.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.
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.
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.
Trial Locations
- Locations (2)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States