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.
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.
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 group | Role | What they receive |
|---|---|---|
| Monitoring by Web application | Experimental | 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. Receives: Other: Monitoring by Web-application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted15 Aug 2016 (estimated)
- Study start8 Sep 2015
- Primary completionSep 2017
- Study completionJan 2018
Why it stopped: Only one center could be open and the center could not include all patients
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, MD, Principal investigator, Institut interrégionaL de Cancérologie - LA MANS
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
- ClinicalTrials.gov ID
- NCT02866851
- Acronym / sponsor ID
- BioConnect / ICO-A-2014-12
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only one center could be open and the center could not include all patients
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 15 Aug 2016 (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.
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).
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring by Web application | Experimental | Other: Monitoring by Web-applicationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Monitoring by Web-applicationAlso: New technologyPatients 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. | Other | Monitoring by Web application |
Primary outcome
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 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).
Time frame: 4 months
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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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.
Fabrice DENIS, MD principal investigator
Institut interrégionaL de Cancérologie - LA MANS
1 site in 1 country: see every site and its status.
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.