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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436669
• Other study ID #: REC 10/H0724/14
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2021
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Belmont	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Philips Healthcare	The Royal Marsden Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary Blood Sample	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	Number of variances in neutrophil and haemoglobin	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
Secondary	Usability	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
Secondary	Performance Evaluation	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