Home Transfusion for HEME

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05509439
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy	Other: Home Transfusion Program Components	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Home Transfusion Program for Patients With Advanced Hematologic Malignancies
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Home Transfusion 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; 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

Outcome Measures

Primary Outcome Measures

1. Enrollment Rate [6 months]

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

2. 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

1. 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.

2. Disenrollment Rate [6 months]

   Proportion of study participants who disenroll from the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Oreofe O Odejide, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oreofe O. Odejide, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT05509439
• Other Study ID Numbers: 22-178
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Oreofe O. Odejide, Principal Investigator, Dana-Farber Cancer Institute: Hematologic Malignancy
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Aug 22, 2022