The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
This study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Patients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Included patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.
It is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.
≥ 18 years old
newly diagnosed with AML within four weeks
scheduled to receive home-based chemotherapy.
Patients who do not understand or speak Danish
Incapable of performing home-based CBC measurements and administration of transfusions.
Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Single group
Feasibility and safety of home-based blood count measurement and transfusions
DeviceFeasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia
Technical Performance of the Hemoscreen Instrument
Number and classification of technical issues encountered by patients using the Hemoscreen instrument, including device malfunctions, failures, and errors in transmission of complete blood count (CBC) measurements. Recorded per transfusion event through hospital records and patient reports; categorized by issue type (e.g., hardware failure, data transmission error).
Self-Administered Blood Measurements at Home
Number of CBC measurements performed by patients at home using the Hemoscreen instrument. Extracted from hospital records and participants' self-reporting.
Self-Administered Blood and Platelet Transfusions at Home
Number of blood and platelet transfusions self-administered at home without direct hospital supervision. Extracted from hospital records and participants' self-reporting.
Replacement of Scheduled Day Hospital Visits by Home Care and Self-Testing
Number of scheduled day hospital visits replaced by successful self-testing and home transfusions. Determined by comparing hospital visit records with home care study documentation.
Change in Quality of Life scores from EORTC QLQ-C30 at baseline and post-second chemotherapy
Quality of Life assessed using the validated EORTC QLQ-C30 questionnaire, which evaluates multiple dimensions of QoL in cancer patients.Patients will complete the QLQ-C30 questionnaire at two time points: at study entry (baseline) and after second chemotherapy course to monitor for any QoL deterioration during participation. Quality of life is measured by the validated QOL-EORTC30 questionnaire at inclusion and end of study. Data will be collected via patient self-report during scheduled visits or remotely as appropriate.
Empowerment
Level of patient empowerment and satisfaction as measured by the Patient Empowerment Scale (cancer), a validated questionnaire assessing patients' sense of empowerment related to their care. Patients will complete the Patient Empowerment Scale at two time points: at study entry (baseline) and after the second chemotherapy course. Data will be collected via patient self-report during scheduled visits or remotely as appropriate.
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