Acute Myeloid Leukemia, Hematologic Malignancy, Myelodysplastic Syndromes, Transfusion Dependent Cytopenias
Conditions
Keywords
home blood transfusions, blood transfusions, RE-AIM, Supportive Care
Brief summary
This is a pilot single arm study to evaluate the feasibility and acceptability of a home blood transfusion program. Patients will be enrolled with hematologic malignancies and other bone marrow failure syndromes who are transfusion dependent and interested in a home blood transfusion program. Participants enrolled in the study will receive 1-5 units of blood products at home. Data on barriers to administration will be recorded. Surveys and qualitative interviews will be completed to better understand acceptability of the program.
Detailed description
The study is a single arm pilot study to evaluate the implementation of a novel home blood transfusion program at Thomas Jefferson University Hospital. The study population will include patients with hematologic malignancies and other bone marrow failure syndromes with transfusion dependent cytopenias. Participants will receive home blood draws and if needed same day transfusions. Data will be collected via surveys at time of each study visit, participant surveys at the end of the intervention as well as a semi structured interview. Each participant in the study will receive 1-2 blood products transfused in the home each week for a total of 5 transfusions. As a result each participant will be eligible to receive transfusions at home for 5 weeks.
Interventions
PROCEDUREHome Blood Transfusion
Participants will be provided with transfusion of blood products, specifically red blood cells and platelets, in the home setting.
Sponsors
American Cancer Society, Inc.
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study * Male or female, over the age of 18 * Must meet definition of transfusion dependence (require at least 2 blood product transfusions over a 28-day period) * Receive their cancer care at SKCCC * Have a history of blood product transfusions and NO history of transfusion reactions, * Live within a 30-mile range of the Center City SKCCC location. * Must be willing to allow people into the home
Exclusion criteria
* An individual who meets any of the following criteria will be excluded from participation in this study: * Patients who have a history of a transfusion reaction * Heart failure as defined by AHA stage C or NYHA Class II-IV * Non-English or Spanish speaking * Are unhoused * Are incarcerated * Have poor venous access * Diagnosis of Solid Tumor malignancy * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a home blood transfusion program utilizing the RE-AIM framework | 5 weeks | The feasibility of the program defined as greater than 80% of home blood product transfusions occur as planned. |
| Acceptability of a home blood transfusion program utilizing the RE-AIM framework | 5 weeks | Surveys and qualitative interviews will be completed to better understand acceptability of the program. Acceptability will be measured using the acceptability of intervention measure. Based on a 5-point Likert scale. Score range: 1 (Completely Disagree) to 5 (Completely Agree) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate patient perspective of home blood transfusions via qualitative analysis. | Within 3 weeks of final home transfusion | Evaluate patient perspective of home blood transfusions via qualitative analysis. Semi-structured interviews will be evaluated through qualitative analysis. All interviews will be digitally recorded and transcribed. Interviews will be analyzed using NVIVO software for coding and analysis. The codebook will be developed using conventional content analysis. All members of the research team will read the first three transcripts and identify concepts, leading to the initial code structure. This initial code structure will be applied to subsequent interviews by two coders and refined to include new themes as they emerge. This iterative process will continue until coders and at least one other team member agree upon a final coding structure, with discrepancies resolved through consensus. The two coders will apply the final structure to all transcripts. Coders will double code about 30-40% of the transcripts. Intercoder reliability will be calculated in NVivo 12 using the κ coefficient. |
Countries
United States
Contacts
Primary ContactAdam Binder, MD
Outcome results
None listed