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CancerBioConnectNCT02866851

Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy

A study testing Monitoring by Web-application in people with Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥ 20%. The use of the web-application their will be proposed . They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond the fifth day of each chemotherapy cycle (to eliminate fevers related to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Monitoring by Web-application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteFrance
Study dates
8 Sep 2015to Jan 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with a histologically proven cancer regardless of the location (solid tumor or not) except brain tumor
  • Patient should receive chemotherapy (any indication) associated with overall risk of neutropenia greater than or equal to 20%
  • Age ≥ 18 years
  • Performance Status ≤ 3
  • Patient with Internet access and an email box
  • Patient affiliated to a social security scheme
  • Patient has given its written consent before any specific procedure for the study

Who cannot join

  • Symptomatic brain metastases
  • Persons deprived of liberty, under guardianship or under curators
  • dementia, mental impairment or psychiatric illness that may affect the patient's informed consent and / or protocol adherence and monitoring of the test
  • Patient unable to submit the protocol followed for psychological, social, family or geographical reasons
  • Pregnant or breastfeeding
  • Patients at risk of severe neutropenia (Absolute Neutrophils Count <0.1 Giga / L within 7 days prior to inclusion, acute leukemia, auto or allograft)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Institut interregionaL de Cancérologie

    Le Mans, 72000

Other trials in France

About this study

Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥ 20%. The use of the web-application their will be proposed .

They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).

Read more

The temperature measurement is performed at home by an infrared forehead thermometer provided as part of the study, in a systematic manner once daily at the same time of day and in case of unexplained fatigue or chills.

Before any fever reported to the physician via the web-application (alert), a questionnaire will be completed by the patient to the search for gravity criteria to assess his condition at home. The patient will be hospitalized immediately if it shows signs of severity in order to document the infection and provide intravenous antibiotics adapted to the clinical condition; in the absence of these signs, the patient will make a count to the nearest lab and will receive oral antibiotics if indicated. The subsequent strategy will be defined by the web-application algorithm to optimize the care of patients.

The ability to use a web-application could allow early detection of complications of post-chemotherapy haematological toxicity and offer a taking over guided by a decision-making algorithm managed by the physician.

The aim is to favour the taking over at home.

Read the detailed description

The hematological toxicity is frequent and sometimes severe complication of chemotherapy used in onco-hematology.

The most frequent is the neutropenia. It is defined by Neutrophils rate lower than 1 Giga/L. The patient can then have a risk of fever or serious infection which requires a hospitalization, an empiric antibiotic therapy and sometimes a dose reduction of chemotherapy which can threaten the patient future. Hospital overall mortality by febrile neutropenia is estimated at 9.5%.

The growth factor allowed to reduce the risk of neutropenia or to shorten the neutropenia. In general, they are suggested in primary prophylaxis for chemotherapy whose risk of febrile neutropenia is superior at 20%.

However, only 20 to 30% of post-chemotherapy fever will be documented. A double and early empiric antibiotic therapy decreases significantly the risk of mortality.

Thrombocytopenia is a less frequent complication than the neutropenia but there is a risk of spontaneous bleeding for the patient when the platelets rate is below 10 Giga/L.

The patient is informed at the beginning of his taking care of the neutropenia risk, fever and hemorrhagic event which can happen at home between two chemotherapies. The patient is in the center of his taking care of and must report quickly all fever or bleeding happening after chemotherapy to evaluate the risk of immediate complication and to propose the appropriate therapeutic strategy. However too many patient with one or two hematological complication during the chemotherapy aren't take care of optimally nor in adapted delay.

The use of a web-application could allow to febrile patient after chemotherapy to benefit of personalized care with a quicker communication of clinical symptoms and blood tests results to the oncologist via this tool.

In practice, patients don't always contact their oncologist in case of fever. On the other hand, the delays for transmission of biological tests at the medical team don't always allow an optimal taking care of and in appropriate delays of hematological toxicity and febrile event of patient during chemotherapy.

The possibility of using a web-application could allow to detect earlier the possible complication of post-chemotherapy hematological toxicity and to suggest a taking care of guided by a decisional algorithm managed by the oncologist. The aim is to privilege the care at home.

The expected benefit for each patient is to have an earlier and adapted care in case of infection and/or bleeding. The use of this web-application could allow, in optimizing the care of chemotherapy-induced neutropenia, to limit the number of hospitalization and the prescription of intravenous antibiotic and to achieve optimally the therapeutic project.

The usual monitoring (oral advice only) would have been proposed at all patient include in this study. It is unlikely that post-chemotherapy fever, neutropenia or thrombocytopenia will supported later than in the usual practice. Therefore it is expected that the use of the web-application will be for the benefit of patient by allowing to detect earlier post-chemotherapy complications and so to propose an optimal take care of for included patients.

Patient must have a chemotherapy schema with a global risk of febrile neutropenia < 20% could use the web-application.

Patients will be informing of the risks of neutropenia, fever and bleeding could happen beyond the 5th day after chemotherapy.

Temperature will be taken at home by an infrared forehead thermometer provided in the study in a systematic once a day at the same time and in case of unusual fatigue or chills.

When a fever is detected by the web-application, a questionnaire will be completed by the patient to find serious symptoms. The aim is to optimize the taking care of patient.

Conditions
Cancer
Being tested
Monitoring by Web-application
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring by Web-applicationOther

    Also called New technology

    Patients have to log in a web-application every day (from D5) to indicate their temperature and the presence of gravity sign in case of fever.

Study groups in NCT02866851
Study groupRoleWhat they receive
Monitoring by Web applicationExperimentalPatients have to log in a web-application every day (from D5) to indicate their temperature and the presence of gravity sign in case of fever.
Receives: Other: Monitoring by Web-application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient compliance with the use of the web-application which will be assessed by the number of completed evaluations compared to the theoretical number of filling.

    Measured: 4 months

  2. The opinion of the patients regarding this application will be assessed through a satisfaction survey completed in the 4th cycle of chemotherapy (3rd cycle for patients receiving 3 CEF100 (Cytoxan-Ellance-Fluorouracil) then Taxotere).

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start8 Sep 2015
  3. Primary completionSep 2017
  4. Study completionJan 2018

Why it stopped: Only one center could be open and the center could not include all patients

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866851
Sponsor's protocol ID
ICO-A-2014-12
Other IDs
2014-A01902-45
Acronym
BioConnect
Status last verified
Jan 2019
First submitted
21 Jul 2016
Last updated
7 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Monitoring by Web-application in people with Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.

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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Jan 2019. 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 France. 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 was stopped early (reason given: Only one center could be open and the center could not include all patients). Results are not available in the source record.

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?

Patient compliance with the use of the web-application which will be assessed by the number of completed evaluations compared to the theoretical number of filling. (time frame: 4 months). The study lists 2 primary outcomes in all. 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 7 Jan 2019.

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