Removing Transfusion Dependence as a Barrier to Hospice Enrollment (BRUOG-407)

December 27, 2025 updated by: Adam Olszewski

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Transfusion support
Patients will be offered symptom-driven transfusion support in addition to standard hospice care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Through study completion, on average 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adam Olszewski

Investigators

  • Principal Investigator: Pamela C Egan, MD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRUOG-407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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