Skip to main content
OpenTrials
Completed

NCT Number: NCT05063591

Removing Transfusion Dependence as a Barrier to Hospice Enrollment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematologic Malignancy Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfusion support

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Adam Olszewski

Other

Registry information

Acronym: BRUOG-407

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.