LeukemiaNCT06487247
HEME Home Transfusion Program
A study testing HEME-Hospice Program in people with Leukemia and Myeloma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloma, Myelodysplastic Syndromes
- What is being tested?
- HEME-Hospice Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of a relapsed/refractory hematologic malignancy
- Age ≥ 18 years
- Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
- Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a severe transfusion reaction
- Patient resides within catchment served by Care Dimensions Hospice
- Physician-estimated prognosis of six months or less
- Identified informal caregiver of enrolled patient with hematologic malignancy
- Age ≥ 18 years
Who cannot join
- Age < 18 years
- Already enrolled in hospice
- Resides in nursing home or assisted living facility
- History of previous serious adverse transfusion reaction
- -Age < 18 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Oreofe Odejide, MD, MPH, 617-632-6864, Oreofe_Odejide@dfci.harvard.edu
Oreofe Odejide, MD, MPH
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Oreofe Odejide, MD, MPH, 617-632-6864, Oreofe_Odejide@dfci.harvard.edu
Oreofe O. Odejide, MD
About this study
Official title: Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.
Read the detailed description
Lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. Transfusions palliate these symptoms and improve quality of life (QOL); yet, most hospices do not provide access to transfusions. Patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. Patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care.
The study team has thus developed a new model of care (HEME-Hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life (QOL), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as QOL and mood of their caregivers. This study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to HEME-Hospice versus usual care. Participants in this study will have access to HEME-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.
- Conditions
- Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy, Hematologic Diseases, Lymphoma
- Being tested
- HEME-Hospice Program
- Keywords
- Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy, Hematologic Diseases, Lymphoma
- Medical subject headings
- Leukemia, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Hematologic Neoplasms, Hematologic Diseases, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEME-Hospice ProgramBehavioural
Also called HEME-Hospice
A care delivery program that combines home-based transfusions with routine home hospice care. Transfusions are administered by trained transfusion nurses. Standard hospice care is provided by an interdisciplinary team of non-transfusion nurse case managers, hospice aides, social workers, and chaplains.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care) | Experimental | Participants assigned to access to HEME-Hospice care who enroll in hospice will have at least once weekly assessment of symptoms of anemia and thrombocytopenia by the study team and will receive transfusions at home as indicated. Individualized care appointments with hospice care team providers, and frequency of visits are determined by individual participant need. Receives: Behavioral: HEME-Hospice Program |
| Arm 2: Usual Care | No intervention | Participants assigned to usual care will receive standard oncology care delivered by the hematologic oncologists. Participants will have access to regular/standard hospice care if they elect to enroll in hospice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospice Enrollment Rate
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Measured: 6 months
Length of Hospice Enrollment
Number of days from hospice enrollment to date of death or hospice disenrollment
Measured: 6 months
Secondary outcomes (13)
Chemotherapy Utilization in the Last 14 Days of Life
Compare chemotherapy use in the last 14 days of life between those with access to HEME-Hospice versus usual care
Measured: Last 14 days of life
Hospitalization Rate
Compare hospitalization (2 or more hospitalizations) in the last 30 days of life between those with access to HEME-Hospice versus usual care
Measured: Last 30 days of life
Intensive care unit (ICU) Admission Rate
Compare ICU admission in the last 30 days of life between those with access to HEME-Hospice versus usual care
Measured: Last 30 days of life
Hospital Death
Compare occurrence of death in the hospital between those with access to HEME-Hospice versus usual care
Measured: Last 30 days of life
High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life
Compare the dollar amount of total expenditures between participants with access to HEME-Hospice versus usual care in the final 30 days of life.
Measured: Last 30 days of life
Patient Quality of life
Assess whether access to HEME-Hospice is superior to usual care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Pal version 4.
Higher scores on the FACIT-Pal version 4 (range 0-184) indicate better QOL.
Measured: 6 months
Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
Assessed by the FACT-Anemia version 4 subscale, a 20-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 80 with higher scores indicating better quality of life with respect to symptoms related to anemia and fatigue.
Measured: 6 months
Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score
Assessed by the FACT-Thrombocytopenia version 4 subscale, a 6-item survey rated on a 5-point Likert-type scale. Score range is from 0 to 24 with higher scores indicating better quality of life with respect to thrombocytopenia-related symptoms.
Measured: 6 months
Patient Anxiety Symptoms
Compare anxiety symptoms between patients with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Measured: 6 months
Patient Depression Symptoms
Compare depression symptoms between patients with access to HEME-Hospice versus usual care, using the Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms.
Measured: 6 months
Caregiver Quality of Life
Assess whether access to HEME-Hospice is superior to usual care with respect to caregiver-reported quality of life (QOL) as measured by the Caregiver Oncology QOL questionnaire.
Higher scores on Caregiver Oncology QOL instrument (range 0-100) indicate better QOL.
Measured: 6 months
Caregiver Anxiety Symptoms
Compare anxiety symptoms between caregivers with access to HEME-Hospice versus usual care, using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Measured: 6 months
Caregiver Depression Symptoms
Compare depression symptoms between caregivers with access to HEME-Hospice versus usual care, using the depression Subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Higher scores on the HADS depression subscale (range 0-21) indicate greater depression symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Sep 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Oreofe Odejide, MD, Dana-Farber Cancer Institute
- Investigators
- Oreofe Odejide, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487247
- Sponsor's protocol ID
- 24-040
- Other IDs
- 1R37CA289639
- Status last verified
- Sep 2025
- First submitted
- 27 Jun 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06487247
- Acronym / sponsor ID
- 24-040
- Conditions
- Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy, Hematologic Diseases, Lymphoma
- Keywords
- Leukemia, Myeloma, Myelodysplastic Syndromes, Hematologic Malignancy, Hematologic Diseases, Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.
Detailed description
Lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. Transfusions palliate these symptoms and improve quality of life (QOL); yet, most hospices do not provide access to transfusions. Patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. Patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care.
The study team has thus developed a new model of care (HEME-Hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life (QOL), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as QOL and mood of their caregivers. This study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to HEME-Hospice versus usual care. Participants in this study will have access to HEME-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care) | Experimental | Behavioral: HEME-Hospice ProgramParticipants assigned to access to HEME-Hospice care who enroll in hospice will have at least once weekly assessment of symptoms of anemia and thrombocytopenia by the study team and will receive transfusions at home as indicated. Individualized care appointments with hospice care team providers, and frequency of visits are determined by individual participant need. |
| Arm 2: Usual Care | No intervention | –Participants assigned to usual care will receive standard oncology care delivered by the hematologic oncologists. Participants will have access to regular/standard hospice care if they elect to enroll in hospice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of a relapsed/refractory hematologic malignancy
- Age ≥ 18 years
- Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
- Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a severe transfusion reaction
- Patient resides within catchment served by Care Dimensions Hospice
Key exclusion criteria (5 listed)
- Age < 18 years
- Already enrolled in hospice
- Resides in nursing home or assisted living facility
- History of previous serious adverse transfusion reaction
- -Age < 18 years
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 |
|---|---|---|
| HEME-Hospice ProgramAlso: HEME-HospiceA care delivery program that combines home-based transfusions with routine home hospice care. Transfusions are administered by trained transfusion nurses. Standard hospice care is provided by an interdisciplinary team of non-transfusion nurse case managers, hospice aides, social workers, and chaplains. | Behavioural | Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care) |
Primary outcome
Hospice Enrollment Rate
Time frame: 6 months
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Length of Hospice Enrollment
Time frame: 6 months
Number of days from hospice enrollment to date of death or hospice disenrollment
13 secondary outcomes
Chemotherapy Utilization in the Last 14 Days of Life
Time frame: Last 14 days of life
Hospitalization Rate
Time frame: Last 30 days of life
Intensive care unit (ICU) Admission Rate
Time frame: Last 30 days of life
Hospital Death
Time frame: Last 30 days of life
High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life
Time frame: Last 30 days of life
Patient Quality of life
Time frame: 6 months
Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
Time frame: 6 months
Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score
Time frame: 6 months
Patient Anxiety Symptoms
Time frame: 6 months
Patient Depression Symptoms
Time frame: 6 months
Caregiver Quality of Life
Time frame: 6 months
Caregiver Anxiety Symptoms
Time frame: 6 months
Caregiver Depression Symptoms
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Oreofe Odejide, MD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEME-Hospice Program in people with Leukemia and Myeloma, run by Dana-Farber Cancer Institute at 2 sites 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oreofe Odejide, MD, MPH (617-632-6864, Oreofe_Odejide@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospice Enrollment Rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Sep 2025.