Home Transfusion Program for Blood Cancers

Recruiting at 1 trial location

Overseen By Oreofe Odejide, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Already in hospice, Nursing home, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new home care program, the HEME-Hospice Program, can improve the quality of life for patients with blood cancers in hospice care. The program provides home blood transfusions to assess their impact on mood, well-being, and the use of end-of-life healthcare services. Participants will either receive these home transfusions or continue with regular hospice care. It suits those with relapsed or hard-to-treat blood cancers who have previously received blood transfusions and live within the Care Dimensions Hospice area. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative care solutions that could enhance hospice experiences.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the HEME-Hospice Program is safe for patients with blood cancers?

Research has shown that home blood transfusions can be safe and effective for patients with blood cancers. These transfusions improve quality of life by addressing symptoms like anemia (low red blood cell count) and thrombocytopenia (low platelet count). Although specific safety data for the HEME-Hospice Program is not available, blood transfusions are a common and well-understood procedure.

In this trial, patients will receive transfusions at home, introducing a new method. The safety of home transfusions relies on healthcare providers carefully monitoring symptoms and needs. Patients in the program will have regular check-ins to ensure safety and comfort. This approach manages symptoms while offering the convenience of home care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEME-Hospice Program because it offers a unique approach to managing blood cancers by providing blood transfusions directly at home for patients in hospice care. Unlike traditional treatments that require frequent hospital visits, this program allows patients to receive necessary care and transfusions in the comfort of their own homes. This approach not only aims to improve patient quality of life by reducing hospital trips but also provides personalized care tailored to individual needs, which could enhance overall treatment satisfaction and effectiveness.

What evidence suggests that the HEME-Hospice Program is effective for improving quality of life in patients with blood cancers?

Research has shown that blood transfusions can greatly improve the quality of life for people with blood cancers. In past studies, patients and their caregivers reported that access to transfusions is essential for their well-being. In this trial, participants in Arm 1 will receive the HEME-Hospice Program, which provides these transfusions at home, combining hospice care with regular transfusions. This approach helps manage symptoms like anemia (low red blood cell count) and thrombocytopenia (low platelet count), common in blood cancer patients. Early findings suggest that this method could make end-of-life care more comfortable by reducing hospital visits and improving mood and quality of life. Participants in Arm 2 will receive usual care, with access to standard oncology and hospice care. ^{1 3 5 6 7}

Who Is on the Research Team?

Oreofe O. Odejide, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with blood-related cancers like leukemia, myelodysplastic syndrome, multiple myeloma, and lymphoma. Participants should be in need of hospice care and could benefit from home blood transfusions.

Inclusion Criteria

My blood cancer has returned or is not responding to treatment.

Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)

Patient resides within catchment served by Care Dimensions Hospice

Exclusion Criteria

Already enrolled in hospice

Resides in nursing home or assisted living facility

History of previous serious adverse transfusion reaction (for Patient Participants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either HEME-Hospice care with home transfusions or usual care based on their oncologist's assignment

6 months

At least once weekly assessment of symptoms

Follow-up

Participants are monitored for quality of life, mood, and healthcare utilization after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HEME-Hospice Program

Trial Overview The study is testing a new HEME-Hospice Program that offers home blood transfusions to see if it improves quality of life, mood, and reduces hospital visits at the end of life compared to usual care.

How Is the Trial Designed?

Group I: Arm 1: Access to home blood transfusions while enrolled in hospice (HEME-Hospice care) Experimental Treatment 1 Intervention

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.

Group II: Arm 2: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A case series involving 101 transfusion procedures for six pediatric patients showed that home transfusions for those in Pediatric Palliative Care were safe, with no reported adverse effects.

Families expressed high satisfaction with home transfusions, appreciating the convenience and reduced disruption to daily life, while the program also resulted in cost savings for the Regional Health System.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Home Transfusions in Pediatric Palliative Care: A Preliminary Report. De Zen, L., Del Rizzo, I., Vendrametto, V., et al.[2022]

Home blood transfusion can significantly improve the comfort and quality of life for patients with chronic anemia by allowing them to avoid the difficult and costly transportation to hospitals for transfusions.

The practice has shown to have few mild adverse events, but its development was previously hindered by a lack of funding and framework until new recommendations were published in 2018, suggesting a potential for growth in this area of healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Home blood transfusion in France: Benefits and development terms]. Charron, J., Gouëzec, H., Bajeux, E.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06487247

NCT06487247 | HEME Home Transfusion Program 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 ...

2. reporter.nih.gov reporter.nih.gov/search/6oOmozNb5UafeV9r7gONVg/project-details/10856355

HEME-Hospice This proposal seeks to test the efficacy of access to a novel model of care delivery that combines palliative home transfusions with core elements of hospice ...

3. trialx.com trialx.com/clinical-trials/listings/308623/heme-home-transfusion-program/

HEME Home Transfusion Program | Clinical Research Trial ... The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life ( ...

4. dana-farber.org dana-farber.org/clinical-trials/24-040

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) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05509439

Study Details | NCT05509439 | Home Transfusion for HEME This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer and are hospice ...

6. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10856355&term=CA289639

HEME-HOSPICE - Funding History - National Cancer Institute Transfusions palliate these symptoms and improve QOL; yet, most hospices do not provide access to transfusions and none provide home transfusions. Faced with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11665515/

Challenges in hospice and end-of-life care in ... The hospice model often does not support ongoing blood transfusions for patients, creating an additional and substantial hurdle to hospice ...