A Phase 1 Trial Assessing the Safety and Performance of the Minicare H-2000 in Home Testing of Blood Counts in Chemotherapy Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Proportion of home tested blood count results transferred to the hospital team on the day of the venous blood test performed prior to the subsequent SACT cycle
研究概览
简要总结
The investigators hypothesise that cancer patients on systemic anticancer therapy can measure a home blood count, temperature, record qualitative data and transfer the results electronically to the hospital clinical team.
A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000 is a new device which facilitates home self-testing of blood count, temperature and symptoms. The four components are i) blood count recorder using a capillary sample obtained via finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported outcomes and iv) secure communication through the 3G network.
The investigators propose a single-centre, non-randomised feasibility study to test the process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood count readings, temperature and qualitative data electronically to the hospital clinical team. The aim is to test training of patients to use a finger-prick method of obtaining blood count, patient ability to perform the test, retention of training, the ability of the Minicare H-2000 to facilitate the data transfer and to test the secondary care interface. This study will provide preliminary data on the potential of Minicare H-2000 to prevent wasted hospital journeys when the blood count has not recovered sufficiently for subsequent SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80 patients to this study which will be performed in addition to current local standard of care.
This study enables identification of suboptimal areas of the process prior to investigating the application of the minicare H-2000 within oncology to improve the clinical patient pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys and hospital resources, reduce non-elective hospital admissions and personalise delivery of SACT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any solid tumour diagnosis being managed by either medical or clinical oncologists.
- •Patients receiving one or more systemic chemotherapy drugs or targeted therapy at Leeds Cancer Centre.
- •Adults ≥ 18 years.
- •Live within boundaries of Local Care Direct service provision.
- •Live in post-code with good 2G, 3G or GPRS connectivity according to coverage map.
排除标准
- •On hormone treatment only for their cancer.
- •Participating in the active phase of a therapeutic clinical trial.
- •Inability to give informed consent due to mental capacity or language barrier.
- •Patient or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result.
- •Known inherited or acquired bleeding disorder.
- •History of haematological malignancy.
- •Known poorly controlled anti-coagulation (INR>3.0 within 6 months)
- •Prisoner in custody of HM Prison Service.
结局指标
主要结局
Proportion of home tested blood count results transferred to the hospital team on the day of the venous blood test performed prior to the subsequent SACT cycle
时间窗: 15-42 days after training, dependent on length of chemotherapy cycle, most commonly 22 days.
次要结局
- Assess proportion of successful tests performed with subsequent cycles.(up to 9 months. Most common maximum of 4.5 months.)
- Patient feedback on willingness to use and ease of use of Minicare H-2000.(15 to 42 days)
- Correlation of capillary granulocyte count with venous laboratory measured neutrophil count pre subsequent SACT cycle.(15 to 42 days, dependent on chemotherapy cycle length, most commonly 22 days.)
- Proportion of home tested blood count results transferred to the hospital team after (i) initial home training (TP1), (ii) forty-eight hours (TP2)(24 to 48 hours)
- Proportion of home tested temperature and questionnaire responses transferred to the hospital after (i) initial home training (TP1), (ii) forty-eight hours (TP2) and (iii) on the day of venous blood test pre subsequent SACT cycle (TP3).(15-42 days from training, dependent on length of chemotherapy cycle, most commonly 22 days.)
- Health-care professional feedback on server clinical interface.(15-42 days, dependent on lenghtof chemotherapy cycle, most commonly 22 days.)
研究者
Dr Geoff Hall
Senior Lecturer & Honorary Consultant in Medical Oncology
University of Leeds