CancerNCT01436669
Study of Home Full Blood Count (FBC) Telemonitoring Device for Chemotherapy Patient
A study testing Home Telemonitoring System (The Zodiac, Philips Health care) in people with Cancer, run by Philips Healthcare at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Home Telemonitoring System (The Zodiac, Philips Health care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Home Telemonitoring System (The Zodiac, Philips Health care)
- Keywords
- Chemotherapy use, Home Monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring | Experimental | All participants will receive a home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home. Receives: Device: Home Telemonitoring System (The Zodiac, Philips Health care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 times per week for 6 weeks
Secondary outcomes (3)
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.
Measured: 3 times per week for 6 weeks
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)
Measured: 3 weeks and 6 weeks of use
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.
Measured: 3 times per week for weeks 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Royal Marsden Hospital
- Responsible party
- Sponsor
- Investigators
- Nic Kent, Study director, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436669
- Sponsor's protocol ID
- REC 10/H0724/14
- Status last verified
- Mar 2021
- First submitted
- 16 Sep 2011
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility Study of a New Home Full Blood Count Tele-monitoring Device for Cancer Patients Receiving Chemotherapy (ETC1)
- ClinicalTrials.gov ID
- NCT01436669
- Acronym / sponsor ID
- REC 10/H0724/14
- Conditions
- Cancer
- Keywords
- Chemotherapy use, Home Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- The Royal Marsden Hospital
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring | Experimental | Device: Home Telemonitoring System (The Zodiac, Philips Health care)All participants will receive a home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Home Monitoring |
Primary outcome
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 secondary outcomes
Number of variances in neutrophil and haemoglobin
Time frame: 3 times per week for 6 weeks
Usability
Time frame: 3 weeks and 6 weeks of use
Performance Evaluation
Time frame: 3 times per week for weeks 1-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nic Kent study director
Philips Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Telemonitoring System (The Zodiac, Philips Health care) in people with Cancer, run by Philips Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary Blood Sample (time frame: 3 times per week for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.