NCT02234453

Home Testing of Blood Counts in Chemotherapy Patients

A Phase 1 Trial Assessing the Safety and Performance of the Minicare H-2000 in Home Testing of Blood Counts in Chemotherapy Patients.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	Minicare H-2000	Patients will use the Minicare H-2000 at home to measure their capillary blood count, temperature, record questionnaire results and transfer the results via the 3G network to the hospital team.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-09-09
• Last updated: 2016-06-17

Locations

1 site across 1 country: United Kingdom