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

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: Lymphoma; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Leukemia; Hematologic Malignancy; Myeloma
• Intervention / Treatment: Other: Transfusion support

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• Sponsor: Adam Olszewski
• Investigators: Principal Investigator: Pamela C Egan, MD, Rhode Island Hospital

Publications and helpful links

Helpful Links

• Cancer Research and Clinical Trials at Lifespan Cancer Institute

Study record dates

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: palliative care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Myeloid; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Leukemia; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Lymphoma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes
• 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