Home Transfusion for HEME

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Home Transfusion Program for Patients With Advanced Hematologic Malignancies

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Other: Home Transfusion Program Components


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Transfusion<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic Malignancy