Skip to main content
OpenTrials
Completed

NCT Number: NCT01436669

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Marsden Hospital

Belmont, Surrey, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Home Telemonitoring System (The Zodiac, Philips Health care)

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Collaborators

  • The Royal Marsden Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 20, 2011
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.