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

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ClinicalTrials.gov Identifier: NCT02866851
Recruitment Status : Terminated (Only one center could be open and the center could not include all patients)
First Posted : August 15, 2016
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief 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 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.


Condition or disease Intervention/treatment Phase
Cancer Other: Monitoring by Web-application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
Actual Study Start Date : September 8, 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Name: New technology




Primary Outcome Measures :
  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. [ Time Frame: 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). [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866851


Locations
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France
Institut interregionaL de Cancérologie
Le Mans, France, 72000
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: Fabrice DENIS, MD Institut interrégionaL de Cancérologie - LA MANS

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT02866851     History of Changes
Other Study ID Numbers: ICO-A-2014-12
2014-A01902-45 ( Other Identifier: French Health Products Safety Agency )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019