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Completed

NCT Number: NCT04454723

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients >= 18 years irrespective of their race, sex and/or other medical history.

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.

Treatment and study plan

Blood and/or platelet transfusion

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

Procedure

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

Primary outcomes

  1. Proportion of subjects with improved quality of life after receiving transfusions.

    Time frame: 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.

  2. Proportion of subjects with improved palliative efficacy after receiving transfusions.

    Time frame: 6 months

    Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Impact of Palliative Transfusions on Quality of Life in Patients With Hematological Malignancies on Hospice - A Case Series Study

Acronym: PalliaQOL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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