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

Philips

Status: Completed

Conditions: Cancer

Treatments: Device: Home Telemonitoring System (The Zodiac, Philips Health care)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01436669

REC 10/H0724/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Home Monitoring

Experimental group

Description:

All participants will receive a home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home.

Treatment:

Device: Home Telemonitoring System (The Zodiac, Philips Health care)