Clinical trial · Observational
The Potential of HemoScreen for Monitoring Blood Values in Cancer Patients at Home
A Feasibility and Usability Study of HemoScreen Hematology Analyzer for Cancer Patients Receiving Chemo and Its Potential for Home Monitoring of Blood Values Before Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To keep cancer patients safe, whilst in chemo therapy, patients come into the hospital for multiple blood tests, in order to provide safe antineoplastic treatment and supportive care. Monitoring of relevant blood values (WBC white blood cell count, total and differentiated, ANC absolute neutrophil count, RBC red blood cell count, HGB hemoglobin and PLT platelets) is usually obtained by venipuncture by a health-care professional at the hospital. HemoScreen is a POCT (point-of-care-technology) automated hematology analyzer that performs complete blood count (CBC) analysis from capillary or venous whole-blood samples. HemoScreen solution has not yet been used by patients to self-test blood cell count, but the investigators hypothesize that cancer patients on systemic anticancer therapy can perform a self-test at home using HemoScreen, and transfer the results to the hospital clinical team, to prevent wasted hospital journeys. This study aims to investigate the feasibility and usability of HemoScreen hematology analyzer for capillary self-testing of blood values in home for cancer patients receiving chemo. The study consists of a quantitative and a qualitative part. The quantitative part is to compare blood values obtained by capillary self-testing using HemoScreen and venous blood values obtained on standard hospital equipment (Sysmex) in patients. The qualitative part will be observational studies and semi-structured interviews with patients as well as health professionals from the department of Clinical Oncology, as they perform a capillary blood test with HemoScreen themselves. Recruitment of participants will take place at the department of Clinical Oncology in Naestved. This present study has two phases. The first phase (1) will investigate feasibility, usability and measurement properties of the HemoScreen CBC analyzer, when patients perform a capillary self-test in the outpatient clinic at Oncology supervised by trained personal. Furthermore, Healthcare professionals will test the capillary blood count method. Phase 1 will be conducted to insure that HemoScreen is safely used for capillary self-testing by patient before initiating phase 2, where the HemoScreen is being sent home with the patients for self-measure at home. In Phase 1, 10 cancer patients as well as 4-10 health professionals will be recruited. In phase 2, 33 cancer patients initiating a chemotherapy treatment will be recruited for testing in their home.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HemoScreen hematology analyzer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- The usability of PixCell HemoScreen for self-testing by cancer patients receiving chemo.
- timeFrame
- 16 weeks
- description
- In phase 1 (ambulatory) and 2 (ambulatory and home): The patients will be observed when they perform self-testing in the ambulatory. The observer records in what order the different steps are conducted, and whether the different steps are performed correctly. The capability of each participant to perform self-testing will be evaluated. An overall capability score between 1-10 (1 low and 10 high performance) will be reported. The observation should identify the specific challenges in self-testing with HemoScreen and potential difficulties for the specific patient group. These observations will be reported. Furthermore, the patients will be interviewed about how they perceive their own performance at self-testing. In phase 2, a semistructured interview will be conducted in patients home to investigate how the patients experience self-testing with HemoScreen at home. Based on observations and qualitative date the usability of HemoScreen in home will be evaluated and reported.
- measure
- Accuracy of capillary blood counts in self-testing with HemoScreen. Comparison of capillary self-test blood counts versus venous blood counts.
- timeFrame
- 16 weeks
- description
- Comparison of capillary and venous blood counts will be performed to investigate the applicability of the capillary self-test performed by the patient. In phase 1 and 2 the patients will perform a capillary self-test with HemoScreen in ambulatory. Furthermore, a venous blood sample from the patient (drawn by nurse) will be analyzed at the Sysmex 9000 (standard procedure) and HemoScreen by nurse. In phase 2, further (approximately 5-6) capillary self-tests will be conducted by patients in patients own home. On the same day of capillary self-testing in home the patients will go to the hospital to have a venous blood sample drawn. The venous blood sample will be analyzed at Sysmex 9000 (standard procedure). Hematological components specified as measure 3, 4, 5 and 6 will be statistically compared with two sampled paired t-test, Deming regression and Pearson's correlation coefficient.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria patients: * Breast cancer patients receiving anti-cancer treatment at the Department of Oncology for outpatients * 18 years old or more Exclusion Criteria patients: * Patients unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and results * Known bleeding disorders * Bad circulation, if the patient cannot get enough blood drops to do the test * Inability to give informed content due to mental capacity or language barrier Inclusion Criteria Health-care professionals: * Working at the Department of Oncology for outpatients * 18 years old or more Exclusion Criteria Health-care professionals: * If unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result * Known bleeding disorders * Bad circulation, if the testperson cannot get enough blood drops to do the test * Inability to give informed content
References
Publications (0)
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