HEME Home Transfusion Program
NCT Number: NCT06487247
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Leukemia|Myeloma|Myelodysplastic Syndromes|Hematologic Malignancy|Hematologic Diseases|Lymphoma
Interventions: BEHAVIORAL: HEME-Hospice Program
Sponsor: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-11
Completion Date: 2029-05-31
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

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.

Primary Outcome Measures: Hospice Enrollment Rate, Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care., 6 months|Length of Hospice Enrollment, Number of days from hospice enrollment to date of death or hospice disenrollment, 6 months
Secondary Outcome Measures: Chemotherapy Utilization in the 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, Last 14 days of life|Hospitalization Rate, Compare hospitalization (2 or more hospitalizations) in the last 30 days of life between those with access to HEME-Hospice versus usual care, Last 30 days of life|Intensive care unit (ICU) Admission Rate, Compare ICU admission in the last 30 days of life between those with access to HEME-Hospice versus usual care, Last 30 days of life|Hospital Death, Compare occurrence of death in the hospital between those with access to HEME-Hospice versus usual care, Last 30 days of life|High-Intensity Healthcare Utilization expenditures in the 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., Last 30 days of life|Patient Quality of life, 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., 6 months|Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score, 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., 6 months|Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score, 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., 6 months|Patient Anxiety Symptoms, 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., 6 months|Patient Depression Symptoms, 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., 6 months|Caregiver Quality of Life, 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., 6 months|Caregiver Anxiety Symptoms, 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., 6 months|Caregiver Depression Symptoms, 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., 6 months