Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice

Not Applicable

Completed

• Conditions: Hematologic Malignancy
• Interventions: Procedure: Blood and/or platelet transfusion; Procedure: Complete blood count (CBC) collection

• Registration Number: NCT04454723
• Lead Sponsor: University of Oklahoma

Brief Summary

The purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.

Detailed Description

This is a non-randomized pilot study to investigate the feasibility of symptom-based blood transfusion in patients with hematologic malignancies enrolling in hospice care.

The study will be a case series involving OU Medical Center (OUMC). Patients will be identified at the University of Oklahoma/Stephenson Cancer Center (OU-SCC) where investigators performing the study will consent and monitor patients. Integris Home Hospice agency will provide hospice patients with blood transfusions in those willing to participate, and the Oklahoma Blood Institute (OBI) will provide the hospice patients with palliative transfusions at home at no cost to the patient, including blood products, transfusion testing, infusions and the nursing staff.

This will be a pilot project including 20 consented patients with hematologic malignancies enrolling in hospice through Integris Home Hospice. The transfusions received will be determined by the hospice team, and will not be based on objective symptom based guidelines. Patients will have the option to either be enrolled on this clinical trial, where they may receive home based blood or platelet transfusions, or be enrolled in any other hospice of their choosing, including the other hospice that will provide home based transfusions. Information will be collected regarding symptoms, Hospice QOL scores and transfusion use, reactions, and time in hospice. Data will be collected until death.

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2020-08-14
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• All patients >= 18 years with a primary diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), "high risk" Non-Hodgkin's Lymphoma (NHL), multiple myeloma (MM) and Myelodysplastic Syndrome (MDS) with a life expectancy of < 6 months who are transfusion dependent. Criteria for transfusion dependence is Symptom Questionnaire symptom grade 2 or higher. The Symptom Questionnaire is based on CTCAE (Common Terminology Criteria for Adverse Events) v5.0, with criteria modified for palliative care patients.
• Patients wanting to enroll in hospice.
• Availability of peripheral IV access line or patient agrees to have semi-permanent IV line placed.

Exclusion Criteria

• Patients with > 6-month survival.
• Patients unwilling to go on hospice.
• Patients with antibodies to blood or platelets that would preclude ability to give blood/platelets without prolonged blood typing and or need for anti-HLA platelets.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranfusions and blood collection	Blood and/or platelet transfusion	Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections. Data on patient demographics, disease, and length of hospice stay will also be collected.
Tranfusions and blood collection	Complete blood count (CBC) collection	Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections. Data on patient demographics, disease, and length of hospice stay will also be collected.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with improved quality of life after receiving transfusions.	6 months	Improved quality of life (QOL) and palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.
Proportion of subjects with improved palliative efficacy after receiving transfusions.	6 months	Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.

Trial Locations

Locations (1)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States