Home Transfusion for HEME

Not Applicable

Recruiting

• Conditions: Hematologic Malignancy

• Registration Number: NCT05509439
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2024-10-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	6 months	Number of patients consented to the study divided by eligible patients approached by the study team
Completion of Home Transfusions and Patient-Reported Data	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 Outcome Measures

Name	Time	Method
Satisfaction Rate	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.
Disenrollment Rate	6 months	Proportion of study participants who disenroll from the study.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States