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

NCT01436669 | Completed

• 1 other identifier: REC 10/H0724/14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Chemotherapy use; Home Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of variances in neutrophil and haemoglobin

  3 times per week for 6 weeks

• Usability

  3 weeks and 6 weeks of use

• Performance Evaluation

  3 times per week for weeks 1-6

Study Arms (1)

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.

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

Interventions

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).

Home Monitoring

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Healthcare: lead
• The Royal Marsden Hospital: collaborator

Study Sites (1)

Royal Marsden Hospital

Belmont, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nic Kent

  Philips Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 20, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

GB (1)