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Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063591
Acronym
BRUOG-407
Enrollment
18
Registered
2021-10-01
Start date
2021-07-09
Completion date
2023-12-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Hematologic Malignancy, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myeloma

Keywords

palliative care

Brief summary

Hospice care at the end of life (EOL) includes a multidisciplinary team that helps patients and families focus on symptom control and quality of life. For patients with solid (e.g. lung, breast) cancers it has been shown to improve quality of life for both patients and families. Unfortunately, patients with blood cancers (e.g. leukemia, lymphoma) often delay their enrollment and receive more aggressive care at the EOL. One factor in this delay is the inability for patients to receive blood transfusions while on hospice. Patients with blood cancers often require frequent blood transfusions near the EOL for symptom control. The structure of Medicare hospice benefit makes coverage for transfusions financially unfeasible for hospice agencies, and therefore patients with blood cancers will delay enrollment onto hospice in order to continue to receive blood transfusions. The objective of this study is to evaluate whether removing this financial burden, through external funding of blood transfusions for patients while on hospice, will encourage patients with blood cancers to enroll on hospice earlier and ultimately improve their and their caregivers EOL care.

Detailed description

The overall objective is to demonstrate the feasibility of providing blood transfusions to patients with HM enrolled on hospice, and to evaluate both EOL care quality outcomes in these patients, and caregiver quality of life and perception of patient EOL care quality. Palliative blood transfusions will be provided to patients on this study free of cost through study funding. The hypothesis is that removing transfusion dependence as a barrier to hospice enrollment for patients with hematologic malignancies will result in improved EOL care quality outcomes. This hypothesis is derived from our previous research demonstrating that for Medicare beneficiaries with HM, transfusion dependence poses a significant barrier to timely hospice referral. The study design is to conduct a single-center, prospective pilot study . Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be pursued for enrollment. These patients will be offered to enroll in this study in which funding will be provided to receive palliative blood transfusions while enrolled on hospice.

Interventions

OTHERTransfusion support

Patients will be offered symptom-driven transfusion support in addition to standard hospice care

Sponsors

Adam Olszewski
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

single-center, prospective pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 and older * Advanced hematologic malignancies * Hospice eligible as determined by their primary hematologist * Have opted to forego further cancer-directed therapy. * Transfusion Dependent: Requiring at least 2 units of blood products

Exclusion criteria

* Patients with major psychiatric illness * Patients without the ability to speak and read English

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care.Through study completion, on average 2 yearsMeasured as: the number of eligible patients approached and number who elect to enter the study and participate in the novel care model rather than through the traditional hospice care model.

Secondary

MeasureTime frameDescription
Time Enrolled on Hospice.From enrollment until death or withdrawal of consent, on average 2 months.Count endpoint: number of days enrolled on hospice
Number of Days in the ICU in the Last 30 Days of LifeLast 30 days of life.Count endpoint: Number of days subject spent in the ICU in the last 30 days of life
Death in an Acute Care HospitalFrom enrollment until death or withdrawal of consent, on average 2 months.Binary endpoint: met if subject passed away in an acute care hospital
Receipt of Chemotherapy in the Last 14 Days of LifeLast 14 days of lifeBinary endpoint: met if subject received chemotherapy in the last 14 days of life

Countries

United States

Participant flow

Pre-assignment details

Of 22 patients and 9 caregivers screened, 10 patients (45%) and 8 caregivers enrolled. 4 screened patients died before consenting.

Participants by arm

ArmCount
Intervention Arm
Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be eligible for enrollment. Transfusion support: Patients will be offered symptom-driven transfusion support in addition to standard hospice care
10
Caregivers
Caregivers of participants in Arm A
8
Total18

Baseline characteristics

CharacteristicCaregiversTotalIntervention Arm
Age, Continuous60 years77.5 years80 years
Diagnosis
Acute myeloid leukemia
0 Participants6 Participants6 Participants
Diagnosis
Other
0 Participants4 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
7 Participants17 Participants10 Participants
Sex: Female, Male
Female
8 Participants12 Participants4 Participants
Sex: Female, Male
Male
0 Participants6 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
10 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care.

Measured as: the number of eligible patients approached and number who elect to enter the study and participate in the novel care model rather than through the traditional hospice care model.

Time frame: Through study completion, on average 2 years

Population: Eligible patients approached for participation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmProportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care.10 Participants
Secondary

Death in an Acute Care Hospital

Binary endpoint: met if subject passed away in an acute care hospital

Time frame: From enrollment until death or withdrawal of consent, on average 2 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmDeath in an Acute Care Hospital0 Participants
Secondary

Number of Days in the ICU in the Last 30 Days of Life

Count endpoint: Number of days subject spent in the ICU in the last 30 days of life

Time frame: Last 30 days of life.

ArmMeasureValue (MEDIAN)
Intervention ArmNumber of Days in the ICU in the Last 30 Days of Life0 days
Secondary

Receipt of Chemotherapy in the Last 14 Days of Life

Binary endpoint: met if subject received chemotherapy in the last 14 days of life

Time frame: Last 14 days of life

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmReceipt of Chemotherapy in the Last 14 Days of Life0 Participants
Secondary

Time Enrolled on Hospice.

Count endpoint: number of days enrolled on hospice

Time frame: From enrollment until death or withdrawal of consent, on average 2 months.

ArmMeasureValue (MEDIAN)
Intervention ArmTime Enrolled on Hospice.13 days

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026