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Home Transfusion for HEME

Primary Purpose

Hematologic Malignancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Transfusion Program Components
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hematologic Malignancy focused on measuring Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home Transfusion

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Disenrollment Rate
Proportion of study participants who disenroll from the study.

Full Information

First Posted
August 18, 2022
Last Updated
October 20, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05509439
Brief Title
Home Transfusion for HEME
Official Title
A Home Transfusion Program for Patients With Advanced Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Hematologic Malignancy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Transfusion
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Home Transfusion Program Components
Intervention 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
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
Number of patients consented to the study divided by eligible patients approached by the study team
Time Frame
6 months
Title
Completion of Home Transfusions and Patient-Reported Data
Description
Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction Rate
Description
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.
Time Frame
3 Weeks
Title
Disenrollment Rate
Description
Proportion of study participants who disenroll from the study.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oreofe O. Odejide, MD,MPH
Phone
(617) 632-6864
Email
Oreofe_Odejide@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oreofe O Odejide, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oreofe O. Odejide, MD, MPH
Phone
617-632-6864
Email
Oreofe_Odejide@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Oreofe O. Odejide, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Home Transfusion for HEME

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