Hematologic MalignancyBRUOG-407NCT05063591
Removing Transfusion Dependence as a Barrier to Hospice Enrollment
A study testing Transfusion support in people with Hematologic Malignancy and Myelodysplastic Syndromes, run by Adam Olszewski at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Myelodysplastic Syndromes, Acute Myeloid Leukemia
- What is being tested?
- Transfusion support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with major psychiatric illness
- Patients without the ability to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Hematologic Malignancy, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Lymphoma, Leukemia, Myeloma
- Being tested
- Transfusion support
- Keywords
- palliative care
- Medical subject headings
- Hematologic Neoplasms, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Lymphoma, Leukemia, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion supportOther
Patients will be offered symptom-driven transfusion support in addition to standard hospice care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transfusion support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, on average 2 years
Secondary outcomes (4)
Time Enrolled on Hospice.
Count endpoint: number of days enrolled on hospice
Measured: 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
Measured: Last 30 days of life.
Death in an Acute Care Hospital
Binary endpoint: met if subject passed away in an acute care hospital
Measured: 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
Measured: Last 14 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start9 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, prospective pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Olszewski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adam Olszewski, Brown University
- Investigators
- Pamela C Egan, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063591
- Sponsor's protocol ID
- BRUOG-407
- Acronym
- BRUOG-407
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2021
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removing Transfusion Dependence as a Barrier to Hospice Enrollment
- ClinicalTrials.gov ID
- NCT05063591
- Acronym / sponsor ID
- BRUOG-407 / BRUOG-407
- Conditions
- Hematologic Malignancy, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Lymphoma, Leukemia, Myeloma
- Keywords
- palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Adam OlszewskiUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Transfusion supportPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with major psychiatric illness
- Patients without the ability to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion supportPatients will be offered symptom-driven transfusion support in addition to standard hospice care | Other | Intervention arm |
Primary outcome
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.
4 secondary outcomes
Time Enrolled on Hospice.
Time frame: 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.
Death in an Acute Care Hospital
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Cancer Research and Clinical Trials at Lifespan Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela C Egan, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfusion support in people with Hematologic Malignancy and Myelodysplastic Syndromes, run by Adam Olszewski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.