NCT02866851

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

July 21, 2016

Last Update Submit

January 4, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    4 months

Study Arms (1)

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.

Other: Monitoring by Web-application

Interventions

Monitoring by Web-applicationOTHER

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.

Also known as: New technology
Monitoring by Web application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut interregionaL de Cancérologie

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Fabrice DENIS, MD

    Institut interrégionaL de Cancérologie - LA MANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 15, 2016

Study Start

September 8, 2015

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations

FR(1)