Clinical trial NCT05509439: Home Transfusion for HEME
Official title: A Home Transfusion Program for Patients With Advanced Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Hematologic Malignancy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 6 months
measure: Completion of Home Transfusions and Patient-Reported Data
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction Rate
timeFrame: 3 Weeks
measure: Disenrollment Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Oreofe O Odejide, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: