SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse (SENTINEL)
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|ClinicalTrials.gov Identifier: NCT02361099|
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: Monitoring by SENTINEL application||Phase 3|
With a 5-year survival of about 15% pulmonary cancer is very poor prognosis. About 70 to 75% of cancers are diagnosed at advanced stages. Relapses are common and rarely curable. At least 75% of relapses are symptomatic and there is no standard monitoring after curative treatment or not. Currently, the most common monitoring strategy involves the completion of a clinical examination every 3 to 6 months associated with chest X-ray or CT-scan.
An intensive clinical and imaging monitoring has not yet shown any survival advantage but monitoring of symptoms appears to have a significant medical and economic advantage compared to imaging monitoring. This non-personalized approach is a source of anxiety for patients, especially with the approach of the date of the imaging assessment. In contrast, this monitoring can leave symptomatic patients with untreated relapse for several weeks because many symptomatic patients wait the date of the imaging assessment to consult.
the investigators have developed a score based on the dynamics and the association of clinical signs to alert the physician to a possible recurrence of lung cancer. The referring physician is alerted so early and convenes the patient for a checkup. One of the explanations which could demonstrate the gain in survival is the possibility offered by the application SENTINEL is to treat the relapses earlier, thus avoiding to wait a too much important deterioration of general condition between two monitoring follow-up more or less spaced.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)|
|Actual Study Start Date :||June 3, 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||March 2018|
Experimental: Monitoring by SENTINEL application
Patients randomized to this arm will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application.
Other: Monitoring by SENTINEL application
Patients will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application
Other Name: new technology
No Intervention: Conventional Monitoring
Patients randomized to this arm will have a CT-scan every 3 months.
- Overall Survival (OS) [ Time Frame: 24 months ]Overall survival is defined as the period between the date of randomization to the date of death from any cause. We will also evaluate in this context the overall survival defined between the date of diagnosis and date of death whatever the cause in order to know more precisely the duration of the disease.
- Quality of Life (QOL) [ Time Frame: 12 month ]The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.
- Depression [ Time Frame: 12 month ]Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.
- Relapse detection time [ Time Frame: 24 month ]The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging
- Performance Status (PS) [ Time Frame: 24 month ]Performance Status will be evaluated according to WHO recommendations.
- Cost of monitoring [ Time Frame: 24 month ]The cost of monitoring will be evaluated from the perspective of health insurance.
- Patient compliance [ Time Frame: 24 month ]Patient compliance to the use of SENTINEL application will be evaluated according to the number of assessments completed (usually 1 per week) compared to the theoretical maximum number filling weekly and monthly the application over time.
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): NCT02361099
|Centre Hospitalier Universitaire|
|Angers, France, 49933|
|Institut de Cancerologie de l'Ouest - site Paul Papin|
|Angers, France, 49933|
|Institut Sainte Catherine|
|Avignon, France, 84918|
|Centre Hospitalier Général|
|Chartres, France, 28018|
|Centre Hospitalier Départemenal|
|La Roche Sur Yon, France, 85925|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Le Mans, France, 72037|
|Centre Catherine de Sienne|
|Nantes, France, 44202|
|Institut de Cancerologie de l'Ouest - site René Gauducheau|
|Saint Herblain, France, 44805|
|Principal Investigator:||Fabrice DENIS, MD||Centre Jean Bernard - LE MANS|