Home Transfusion Program for Blood Cancer

Overseen By Oreofe O. Odejide, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Congestive heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if home-based blood transfusions provide a good and comfortable option for people with blood cancers. Participants will fill out questionnaires, participate in brief interviews, and receive transfusions as needed, all from home. Eligible patients must have a blood cancer diagnosis, a history of blood transfusions without issues, and an expected need for support for about six more months. Participants must also have a caregiver living with them and reside in an area served by a hospice care provider. As an unphased trial, this study offers a unique opportunity to explore innovative care options in the comfort of home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this home transfusion program is safe for patients with blood cancer?

Research shows that receiving blood transfusions at home can be safe for people with blood cancer. Previous studies have examined similar home transfusion setups and found them well-tolerated, without reporting any major issues related to the transfusion process itself.

The goal is to shift the blood transfusion process from the hospital to the comfort of a patient's home. This change does not alter the transfusion procedure, which remains a common and safe practice in hospitals. The primary difference lies in the location.

Although specific studies on home transfusions for blood cancer did not provide detailed safety data, the absence of major safety concerns in earlier research is promising. It suggests that home transfusions could be as safe as those conducted in hospitals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home Transfusion Program for blood cancer because it brings the convenience and comfort of blood transfusions directly to patients' homes. Unlike traditional transfusion treatments that require hospital visits, this program allows for necessary blood draws and transfusions in a familiar environment, potentially reducing stress and travel burdens. Additionally, the program includes regular questionnaires and brief interviews, providing personalized care and close monitoring of patients' well-being throughout the six-month study period. This innovative approach could significantly enhance the quality of life for patients managing blood cancer.

What evidence suggests that the Home Transfusion Program is effective for blood cancer patients?

Research has shown that receiving blood transfusions at home can benefit people with blood cancers. One study found that home transfusions are safe and effective for patients who are very ill and require regular blood transfusions. Another study examined a program combining home transfusions with hospice care and found it improved patients' quality of life by allowing them to remain at home. This trial will evaluate the Home Transfusion Program, which aims to make care more comfortable and convenient. Overall, early evidence suggests that home transfusion programs could be a promising way to manage blood cancer symptoms at home. ^{1 2 3 5 6}

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 adults over 18 with advanced blood cancers who've had at least one safe transfusion, are under the care of DFCI, and have a prognosis of six months or less. They must live with an adult caregiver within a specific area served by Care Dimensions Hospice.

Inclusion Criteria

Physician-estimated prognosis of six months or less

Has an adult informal caregiver that lives in the same residence

Patient resides within catchment served by Care Dimensions Hospice

Exclusion Criteria

Does not have an identified adult informal caregiver who lives in the same residence

I am under 18 years old.

History of previous serious adverse transfusion reaction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Transfusion Program

Participants receive home blood transfusions, complete questionnaires, and participate in interviews and blood draws as needed

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Transfusion Program Components

Trial Overview The study is evaluating the effectiveness of administering blood transfusions at home for patients with blood cancers. It aims to determine if this approach is practical and well-received by both patients and their caregivers.

How Is the Trial Designed?

Group I: Home Transfusion Experimental Treatment 1 Intervention

This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed. * Home Transfusion Program Components * Participants will be in the research study for up to six months

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

A pilot study involving 71 patients demonstrated that home hemotherapy is a safe and effective option, with no interruptions needed during 137 home transfusions of red blood cells and platelets.

The program's success relies on thorough staff education and adherence to clinical guidelines, with an average of 4.36 hours of nursing time per patient for transfusion-related care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiation of a home hemotherapy program using a primary nursing model. Crocker, KS., Coker, MH.[2010]

A 5-year study involving 211 patients with myelodysplastic syndromes (MDS) demonstrated that home care transfusions are a reliable and safe option for managing these patients.

The dedicated home care service significantly improved the quality of life for frail MDS patients by reducing the need for hospital admissions and outpatient visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusions at home in patients with myelodysplastic syndromes. Niscola, P., Tendas, A., Giovannini, M., et al.[2019]

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]

The first study of home hematopoietic cell transplantation (HCT) in the U.S. showed that patients receiving home HCT had similar clinical outcomes to those receiving standard treatment, with a notable decrease in relapse rates within one year.

Patients undergoing autologous home HCT were able to maintain their quality of life, indicating that this model may enhance patient well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Hematopoietic Cell Transplantation in the United States. Sung, AD., Giri, VK., Tang, H., et al.[2023]

Patients who received home care during the acute post-transplantation phase reported higher satisfaction with their care compared to those treated in the hospital, indicating that home care can be a viable option for patient support.

The study highlights that patients valued safety, empathy, and continuous information from healthcare staff, suggesting that these factors are crucial for enhancing patient experiences regardless of the care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital care or home care after allogeneic hematopoietic stem cell transplantation--patients' experiences of care and support. Bergkvist, K., Larsen, J., Johansson, UB., et al.[2015]

Home transfusion (HT) is a feasible and safe practice for patients receiving specialized care at home, with a low adverse event rate of 2.68% over 2126 transfusion episodes involving 613 patients.

The study found that HT can reduce hospital readmissions and is sustainable when conducted by well-trained staff under specific protocols, highlighting its potential as an effective component of Hospital at Home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home transfusion: three decades of practice at a tertiary care hospital. García, D., Aguilera, A., Antolín, F., et al.[2019]

North Middlesex Hospital has successfully implemented a home transfusion program for patients with beta-thalassemia major over three years, allowing trained relatives to supervise red-cell transfusions at home.

This program has led to increased patient comfort, fewer absences from school or work, reduced hospital bed usage, and higher satisfaction among patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home blood transfusion programme for beta-thalassaemia patients. Madgwick, KV., Yardumian, A.[2019]

Citations

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

NCT06487247 | HEME Home Transfusion Program 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.

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. 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 ...

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425008383

Effectiveness and Safety of Home-Based RBC ... To evaluate the effectiveness, safety, and procedural characteristics of home-based RBC-TF in terminally ill patients with hematological ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06487247/heme-home-transfusion-program

HEME Home Transfusion Program | Clinical Research Trial ... This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, ...