Clinical trial NCT01436669: Study of Home Full Blood Count (FBC) Telemonitoring Device for Chemotherapy Patient
Official title: Effectiveness and Feasibility Study of a New Home Full Blood Count Tele-monitoring Device for Cancer Patients Receiving Chemotherapy (ETC1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Chemotherapy use
Home Monitoring
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: The Royal Marsden Hospital
First posted: 2011-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Capillary Blood Sample
timeFrame: 3 times per week for 6 weeks
Secondary outcomes:
measure: Number of variances in neutrophil and haemoglobin
timeFrame: 3 times per week for 6 weeks
measure: Usability
timeFrame: 3 weeks and 6 weeks of use
measure: Performance Evaluation
timeFrame: 3 times per week for weeks 1-6
Other outcomes:
Locations:
city: Belmont
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Philips Healthcare
name: Nic Kent
role: STUDY_DIRECTOR
References: