SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse (SENTINEL)

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)

This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Monitoring by SENTINEL application

Detailed Description

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
• Enrollment (Actual): 133
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire
  • Angers, France, 49933
    • Institut de cancérologie de l'Ouest - Site Paul Papin
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Chartres, France, 28018
    • Centre Hospitalier General
  • La Roche Sur Yon, France, 85925
    • Centre Hospitalier Départemenal
  • Le Mans, France, 72000
    • Centre Jean Bernard
  • Le Mans, France, 72037
    • Centre Hospitalier
  • Nantes, France, 44202
    • Centre Catherine de Sienne
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Site René Gauducheau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient with lung cancer (NSCLC and SCLC), histologically proven
2. Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
3. Age ≥ 18 ans
4. PS ≤ 2 within 15 days before enrollment

5. Patient having:

   • finished his cancer treatment in the last 3 months by:

     • Surgery or
     • Surgery then adjuvant chemotherapy or
     • Concomitant radio-chemotherapy or
     • Conventional or stereotactic radiotherapy or
     • 1st or 2nd line chemotherapy
   • treatment with TKI (tyrosine kinase inhibitor) in 1st or 2nd line or maintenance treatment with Alimta® and / or Avastin® or Gemzar® well tolerated (SENTINEL 's score with this treatment (TKI or maintenance) to its latest assessment.
6. Patient with an initial SENTINEL score ≤ 6
7. Patient with internet access and an e-mail box
8. Patient affiliated to a social security scheme
9. Patient has given its written consent before any specific procedure from protocol

Exclusion Criteria:

1. Patient whose disease has progressed at the end of the specific treatment
2. Symptomatic brain metastases
3. Persons deprived of liberty or under guardianship or curators
4. Dementia, mental alteration or psychiatric pathology that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
5. Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
6. Pregnant or breastfeeding women
7. Patient participating in another interventional study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: new technology
No Intervention: Conventional Monitoring; Patients randomized to this arm will have a CT-scan every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL)	The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.	12 month
Depression	Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.	12 month
Relapse detection time	The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging	24 month
Performance Status (PS)	Performance Status will be evaluated according to WHO recommendations.	24 month
Cost of monitoring	The cost of monitoring will be evaluated from the perspective of health insurance.	24 month
Patient compliance	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.	24 month

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: SIVAN Innovation Ldt
• Investigators: Principal Investigator: Fabrice DENIS, MD, Centre Jean Bernard - LE MANS

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: WP-2018-01; 2014-A00263-44 (Other Identifier: RCB)