Home Transfusion for HEME

A Home Transfusion Program for Patients With Advanced Hematologic Malignancies

The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: Home Transfusion Program Components

Detailed Description

This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute.

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 eligible.

10 Caregivers of enrolled patients will also be invited to participate if interested.

This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.

Participants will be in the research study for up to six months.

It is expected that about 20 people will take part in this research study.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with advanced hematologic malignancies:

  • Diagnosis of a 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 serious adverse transfusion reaction
  • 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

• Caregivers:

  • Identified informal caregiver of enrolled patient with hematologic malignancy
  • Age ≥ 18 years

Exclusion Criteria:

• Patients

  • Age < 18 years
  • Does not have an identified adult informal caregiver who lives in the same residence
  • History of previous serious adverse transfusion reaction
  • Presence of decompensated congestive heart failure

• Caregiver

  • Age < 18 years

  • Our study will exclude members of the following special populations:

    • Adults unable to consent
    • Individuals who are not yet adults (infants, children, teenagers)
    • Pregnant women
    • Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home Transfusion; 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

Other: Home Transfusion Program Components; The Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment & administration, (4) usual elements of hospice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate	Number of patients consented to the study divided by eligible patients approached by the study team	6 months
Completion of Home Transfusions and Patient-Reported Data	Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Rate	Proportion of enrolled patients who are satisfied with the home transfusion program and proportion of enrolled patients who are likely to recommend the home transfusion program.	3 Weeks
Disenrollment Rate	Proportion of study participants who disenroll from the study.	6 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Oreofe O Odejide, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Actual): May 13, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Hematologic Malignancy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 22-178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No