NCT05063591 · REGISTRY CONDITION SEARCH

Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2026-01-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

Time Enrolled on Hospice.

→

outcome · POSTED

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

→

outcome · POSTED

Death in an Acute Care Hospital

→

outcome · POSTED

Receipt of Chemotherapy in the Last 14 Days of Life

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Other: Transfusion support
label
Intervention arm
type
EXPERIMENTAL

interventions

arm Group Labels
Intervention arm
description
Patients will be offered symptom-driven transfusion support in addition to standard hospice care
name
Transfusion support
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

intervention Model Description

single-center, prospective pilot study

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care.
time Frame
Through study completion, on average 2 years

secondary Outcomes

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

Full study description

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.

Source references