Clinical trial NCT04454723: Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice
Official title: Impact of Palliative Transfusions on Quality of Life in Patients With Hematological Malignancies on Hospice - A Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: hospice
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects with improved quality of life after receiving transfusions.
timeFrame: 6 months
measure: Proportion of subjects with improved palliative efficacy after receiving transfusions.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jennifer Holter, MD
role: PRINCIPAL_INVESTIGATOR
References: