Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06487247

Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial

Led by Dana-Farber Cancer Institute · Updated on 2025-09-17

700

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dana-Farber Cancer Institute

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new care program called HEME-Hospice that offers home blood transfusions for patients with blood cancers who are enrolled in hospice. The study compares this program to usual care to see if it improves hospice enrollment, quality of life, mood, and end-of-life healthcare use for patients with hematologic malignancies and their caregivers. Patients with blood cancers often face symptoms like fatigue and bleeding that transfusions can ease, but most hospices do not provide transfusions, limiting access to hospice care. The study is a cluster randomized trial where hematologic oncologists are randomly assigned to provide either access to the HEME-Hospice program or usual care. Patients whose doctors are assigned to HEME-Hospice will receive weekly symptom assessments and home transfusions as needed, with hospice care tailored to individual needs. Those in usual care receive standard oncology treatment and may enroll in regular hospice care if they choose. Participants will be monitored over six months for hospice enrollment rates, length of hospice stay, quality of life, mood, and healthcare utilization near the end of life. Assessments include patient and caregiver quality of life, anxiety, depression, and hospital use during the last month of life. The study team provides ongoing symptom evaluation and records transfusion treatments, aiming to understand how home transfusions affect patient and caregiver experiences and healthcare outcomes in hospice.

CONDITIONS

Brief Title

HEME Home Transfusion Program

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a relapsed or refractory hematologic malignancy
  • Age 18 years or older
  • Receipt of primary oncologic care at Dana-Farber Cancer Institute with at least 2 outpatient visits in the past 12 months
  • Has received at least one red blood cell or platelet transfusion since blood cancer diagnosis without a severe transfusion reaction
  • Resides within the area served by Care Dimensions Hospice
  • Physician-estimated prognosis of six months or less
  • Identified informal caregiver aged 18 years or older for enrolled patient
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Already enrolled in hospice
  • Resides in a nursing home or assisted living facility
  • History of serious adverse transfusion reaction
  • Caregiver under 18 years of age

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 6 months

Participants receive care according to their assigned group. Those with access to HEME-Hospice care who enroll in hospice receive at least weekly assessments and transfusions at home as needed, along with individualized hospice care. Participants in usual care receive standard oncology and hospice care if elected.

At least weekly visits for participants enrolled in HEME-Hospice care; visit frequency varies with individual need for hospice care

Follow-up

Duration - Up to 6 months

Participants are monitored for hospice enrollment, quality of life, mood, healthcare utilization, and caregiver outcomes through the study duration.

Visits and assessments conducted as part of ongoing care and study monitoring

Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

Actively Recruiting

2

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

O

Oreofe Odejide, MD, MPH

S

Sunny Rosenthal, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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