Home Transfusion for HEME

Trial Title: Home Transfusion for HEME

NCT ID: NCT05509439

Condition: Hematologic Malignancy

Conditions: Official terms:
Neoplasms
Hematologic Neoplasms

Conditions: Keywords:
Hematologic Malignancy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Home Transfusion Program Components
Description: 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
Arm group label: Home Transfusion

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Oreofe O. Odejide, MD, MPH

Phone: 617-632-6864
Email: Oreofe_Odejide@dfci.harvard.edu

Investigator:
Last name: Oreofe O. Odejide, MD
Email: Principal Investigator

Start date: October 31, 2024

Completion date: August 31, 2025

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05509439