Removing Transfusion Dependence as a Barrier to Hospice Enrollment

NCT ID: NCT05063591

Last Updated: 2026-01-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Hematologic Malignancy Myelodysplastic Syndromes Acute Myeloid Leukemia Lymphoma Leukemia Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-center, prospective pilot study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transfusion support

Intervention Type OTHER

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

Interventions

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Transfusion support

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adam Olszewski

OTHER

Sponsor Role lead

Responsible Party

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Adam Olszewski

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pamela C Egan, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.lifespan.org/centers-services/cancer-research-and-clinical-trials

Cancer Research and Clinical Trials at Lifespan Cancer Institute

Other Identifiers

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BRUOG-407

Identifier Type: -

Identifier Source: org_study_id

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