Cancer Clinical Trial
Official title:
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
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.
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.
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