Removing Transfusion Dependence as a Barrier to Hospice Enrollment

NCT05063591 | Completed Results DMC

• 1 other identifier: BRUOG-407
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

palliative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time 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

  Last 30 days of life.

• Death 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

  Last 14 days of life

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

Transfusion support OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Adam Olszewski: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Links

• Cancer Research and Clinical Trials at Lifespan Cancer Institute

MeSH Terms

Conditions

Hematologic Neoplasms; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Lymphoma; Leukemia; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Roxanne Wood
• Organization: Brown University

roxanne_wood@brown.edu

401-863-3000

Study Officials

• Pamela C Egan, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: single-center, prospective pilot study

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 1, 2021
• Study Start: July 9, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)