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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The usability of PixCell HemoScreen for self-testing by cancer patients receiving chemo.
研究概览
简要总结
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.
详细描述
Background In Denmark the specialty of clinical oncology, provides complex and high-risk medical treatment to patients diagnosed with solid malignancies. To keep patients safe, whilst in therapy (with a curative or palliative intend), patients come into the hospital for multiple blood tests, physical evaluation, registration and treatment of possibly life-threatening adverse effects, all in order to provide safe antineoplastic treatment and supportive care. A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic anti-cancer therapy and can be life-threatening when complicated by sepsis. Neutrophil count is usually obtained by venipuncture by a health-care professional. Correspondingly this applies for the loss of blood production (anemia) and loss of production of blood platelets (thrombocytopenia).
Exploring new ways to closely monitor and treat future cancer patients aiming at increasing quality of life, as well as reducing the cost in hospital tests and admissions, must be given high priority.
HemoScreen is a POCT automated hematology analyzer that performs complete blood count (CBC) analysis from capillary or venous whole-blood samples, using a single use self-contained cartridge. The cartridge is preloaded with all required reagents. After analysis, the results are displayed and can be saved, printed, or exported to another digital system. The HemoScreen Analyzer provides 20 standard CBC parameters in approximately 6 minutes RBC, absolute WBC count, WBC 5-part differential and PLT.
The HemoScreen CBC was developed to be used by professionals and therefore, the HemoScreen solution has not yet been used by patients to self-test complete blood cell count.
The investigators hypothesize that cancer patients on systemic anticancer therapy can measure a home blood count using HemoScreen, record quantitative data and transfer the results to the hospital clinical team. Future intentions are to trial the use of the HemoScreen CBC analyzer to reduce frequency and severity of neutropenia, anemia and thrombocytopenia complications, prevent wasted hospital journeys and hospital resources, reduce non-elective hospital admissions and personalize delivery of anticancer treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The usability of PixCell HemoScreen for self-testing by cancer patients receiving chemo.
时间窗: 16 weeks
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.
Accuracy of capillary blood counts in self-testing with HemoScreen. Comparison of capillary self-test blood counts versus venous blood counts.
时间窗: 16 weeks
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.
WBC (White blood cell) count
时间窗: 16 weeks
The total count of the white blood cells as well as differentiated count of white blood cells will be measured on HemoScreen as well as Sysmex 9000. The differentiated counts includes: Neutrophilocytes (10\^9/L ) Lymphocytes (10\^9/L ) Monocytes (10\^9/L ) Eosinophilocytes (10\^9/L ) Basophilocytes (10\^9/L ) Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.
RBC (Red blood cell) count
时间窗: 16 weeks
The count of the red blood cells will be measured on HemoScreen as well as Sysmex 9000. The red blood cells is measured in unit: 10\^9/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.
HGB (Hemoglobin)
时间窗: 16 weeks
Hemoglobin will be measured on HemoScreen as well as Sysmex 9000. Hemoglobin is measured in unit: mmol/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.
PLT (Platelets) count
时间窗: 16 weeks
The count of platelets will be analyzed on HemoScreen and Sysmex 9000. Platelets is measured in unit: 10\^9/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.
次要结局
未报告次要终点
研究者
Niels Henrik Holländer
Chief physician, MD
Naestved Hospital