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Completed

NCT Number: NCT05509439

Home Transfusion for HEME

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Transfusion Program Components

Other

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

Primary outcomes

  1. Enrollment Rate

    Time frame: 6 months

    Number of patients consented to the study divided by eligible patients approached by the study team

  2. Completion of Home Transfusions and Patient-Reported Data

    Time frame: 6 months

    Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection

Secondary outcomes

  1. Satisfaction Rate

    Time frame: 3 Weeks

    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.

  2. Disenrollment Rate

    Time frame: 6 months

    Proportion of study participants who disenroll from the study.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

A Home Transfusion Program for Patients With Advanced Hematologic Malignancies

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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