Study of Home Full Blood Count (FBC) Telemonitoring Device for Chemotherapy Patient

March 17, 2021 updated by: Philips Healthcare

Effectiveness and Feasibility Study of a New Home Full Blood Count Tele-monitoring Device for Cancer Patients Receiving Chemotherapy (ETC1)

The Zodiac, a Philips healthcare telemonitoring system has been devised to allow cancer patients receiving chemotherapy to test their blood count at home. It is anticipated that the system will allow patients and clinicians to reduce the toxic effects of chemotherapy by early diagnosis of neutropenia, anaemia and any associated complications of chemotherapy. It is also anticipated that the system will also allow clinicians to better manage the scheduling of chemotherapy regimes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Philips Healthcare has devised a new home full blood count (FBC) home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count). The system will also allow patients to record their temperature and symptoms. The Philips home telemonitoring system is called the Zodiac and consists of a telecommunications hub connected to a haematology analyser. The Hub connects to medical device software running on a remote server which controls the flow of information between the Hub and the clinician. This is designed to enable the patient to self test their full blood count in their home and transmit the data remotely to a clinician for review. In addition to testing their full blood count, the patients can input their temperature and any symptoms they have onto the device. The clinician will then be able to send appropriate instructions back to the patient. The Philips Zodiac system can also send a preprogrammed automated message based on the results of testing.

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • Surrey
      • Belmont, Surrey, United Kingdom
        • Royal Marsden Hospital

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

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, age > 18.
  2. Able to give informed written consent in the English language.
  3. Diagnosis of cancer and receiving chemotherapy or with a planned chemotherapy start date within 2 weeks of enrolment.
  4. Patients who are able to perform finger prick test to obtain capillary blood.

Exclusion Criteria:

  1. Inability to give informed consent due to mental capacity or language problems.
  2. Patients at risk of bruising or bleeding as a result of their disease or treatment.
  3. Patients at risk of bruising or bleeding due to anticoagulants (heparin or warfarin), aspirin or thrombocytopenia (platelet count <80).
  4. Patients with diabetes mellitus
  5. Patients with peripheral neuropathy

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home Monitoring
All participants will receive a home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home.
Device: Home Telemonitoring System (The Zodiac, Philips Health care)
Full blood count (FBC) home tele-monitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capillary Blood Sample
Time Frame: 3 times per week for 6 weeks
To achieve a read out result of a full blood count (haemoglobin, haematocrit, white cell count and neutrophil count) from capillary blood obtained by finger prick and analysed in the Philips Zodiac system that varies by no more than 15% from a sample reported by the standard hospital based laboratory analyser for white cell count, haemoglobin and haematocrit using venous blood.
3 times per week for 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of variances in neutrophil and haemoglobin
Time Frame: 3 times per week for 6 weeks
To measure the number of variances in the neutrophil and haemoglobin values between the Philips Zodiac system and hospital laboratory analyser, which could result in a different clinical decision being made based on the management of patients at risk of neutropenia and anaemia.
3 times per week for 6 weeks
Usability
Time Frame: 3 weeks and 6 weeks of use
To document the level of satisfaction and feasibility using questionnaires, in the use of the Philips Zodiac system (training, ease of use, performing a blood test and preference for home testing versus hospital testing)
3 weeks and 6 weeks of use
Performance Evaluation
Time Frame: 3 times per week for weeks 1-6
The questionnaire will assess the patients response to the flow of information via the server software, i.e. the ability of the Philips Zodiac system to provide the patient with a correct automated message or message from a clinician based on the results of the testing; the ability of patients to receive and understand the system messages; and, the satisfaction of patients with the Philips Zodiac System in terms of training issues, ease of use, performing a blood test, performing quality control tests and preference for home testing versus hospital testing.
3 times per week for weeks 1-6

Collaborators and Investigators

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

Sponsor

Philips Healthcare

Collaborators

The Royal Marsden Hospital

Investigators

  • Study Director: Nic Kent, Philips Healthcare

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

June 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

September 16, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (ESTIMATE)

September 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC 10/H0724/14

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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