Home Testing of Blood Counts in Chemotherapy Patients
Research type
Research Study
Full title
A Phase 1 Trial Assessing the Safety and Performance of the Minicare H-2000 in Home Testing of Blood Counts in Chemotherapy Patients.
IRAS ID
158946
Contact name
Geoff Hall
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
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.
We 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 trial management team in secondary care. 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. We 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-H2000 within oncology to improve the clinical patient pathway. Our ongoing intentions are to trial the use of the Minicare H-2000 to reduce frequency and severity of neutropenic complications, reduce non-elective hospital admissions and to prevent wasted hospital journeys and hospital resources.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1224
Date of REC Opinion
5 Dec 2014
REC opinion
Further Information Favourable Opinion