Cancer Clinical Trial
Official title:
A Phase 1 Trial Assessing the Safety and Performance of the Minicare H-2000 in Home Testing of Blood Counts in Chemotherapy Patients.
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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