Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice
Primary Purpose
Hematologic Malignancy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood and/or platelet transfusion
Complete blood count (CBC) collection
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Malignancy focused on measuring hospice
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.
Sites / Locations
- Stephenson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tranfusions and blood collection
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion of subjects with improved quality of life after receiving transfusions.
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.
Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04454723
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
hospice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranfusions and blood collection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood and/or platelet transfusion
Intervention Description
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
Intervention Name(s)
Complete blood count (CBC) collection
Intervention Description
CBC will be collected from patients weekly while on this protocol.
Primary Outcome Measure Information:
Title
Proportion of subjects with improved quality of life after receiving transfusions.
Description
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.
Time Frame
6 months
Title
Proportion of subjects with improved palliative efficacy after receiving transfusions.
Description
Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Holter, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Palliative Transfusions on Quality of Life in Patients With Blood Cancers on Hospice
We'll reach out to this number within 24 hrs