Home Testing of Blood Counts in Chemotherapy Patients

June 16, 2016 updated by: Dr Geoff Hall, University of Leeds

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James's Teaching Hospital, Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
15-42 days after training, dependent on length of chemotherapy cycle, most commonly 22 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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.
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.
Time Frame: 15 to 42 days, dependent on chemotherapy cycle length, most commonly 22 days.
Accuracy of the Minicare H-2000 granulocyte measuring technology will be confirmed using Pearson's correlation co-effcient and R squared.
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
24 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

Philips Healthcare

Investigators

  • Principal Investigator: Geoff Hall, PhD, FRCP, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MO14/11295

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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