Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Monitoring by Web application
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.
干预措施: Monitoring by Web-application (Other)
结局指标
主要结局
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).
时间窗: 4 months
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.
时间窗: 4 months
次要结局
未报告次要终点