An interventional study of Minicare H-2000 in Cancer, sponsored by University of Leeds. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by University of Leeds · Not applicable, Interventional, and Health services research
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.
University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult patients with solid tumours receiving systemic anti-cancer therapy who are able to use the Minicare H-2000.
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.
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
Time frame: 15-42 days after training, dependent on length of chemotherapy cycle, most commonly 22 days.
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).
Time frame: 15-42 days from training, dependent on length of chemotherapy cycle, most commonly 22 days.
Patient feedback on willingness to use and ease of use of Minicare H-2000.
Time frame: 15 to 42 days
Assess proportion of successful tests performed with subsequent cycles.
Time frame: up to 9 months. Most common maximum of 4.5 months.
Health-care professional feedback on server clinical interface.
Time frame: 15-42 days, dependent on lenghtof chemotherapy cycle, most commonly 22 days.
Correlation of capillary granulocyte count with venous laboratory measured neutrophil count pre subsequent SACT cycle.
Accuracy of the Minicare H-2000 granulocyte measuring technology will be confirmed using Pearson's correlation co-effcient and R squared.
Time frame: 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)
Time frame: 24 to 48 hours
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Leeds