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

NCT ID: NCT04454723

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2023-08-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematologic Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tranfusions and blood 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.

Group Type EXPERIMENTAL

Blood and/or platelet transfusion

Intervention Type PROCEDURE

The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.

Complete blood count (CBC) collection

Intervention Type PROCEDURE

CBC will be collected from patients weekly while on this protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood and/or platelet transfusion

The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.

Intervention Type PROCEDURE

Complete blood count (CBC) collection

CBC will be collected from patients weekly while on this protocol.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Holter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OU-SCC-PalliativeQOL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post Transplant Donor Lymphocyte Infusion
NCT00167180 TERMINATED PHASE2