SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse (SENTINEL)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Monitoring by SENTINEL application
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient with lung cancer (NSCLC and SCLC), histologically proven
- Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
- Age ≥ 18 ans
- PS ≤ 2 within 15 days before enrollment
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.
- Patient with an initial SENTINEL score ≤ 6
- Patient with internet access and an e-mail box
- Patient affiliated to a social security scheme
- Patient has given its written consent before any specific procedure from protocol
Exclusion Criteria:
- Patient whose disease has progressed at the end of the specific treatment
- Symptomatic brain metastases
- Persons deprived of liberty or under guardianship or curators
- 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
- Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
- Pregnant or breastfeeding women
- Patient participating in another interventional study
Sites / Locations
- Centre Hospitalier Universitaire
- Institut de Cancerologie de l'Ouest - site Paul Papin
- Institut Sainte Catherine
- Centre Hospitalier Général
- Centre Hospitalier Départemenal
- Centre Jean Bernard
- Centre Hospitalier
- Centre Catherine de Sienne
- Institut de Cancerologie de l'Ouest - site René Gauducheau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Monitoring by SENTINEL application
Conventional Monitoring
Arm Description
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.
Patients randomized to this arm will have a CT-scan every 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Depression
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
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)
Performance Status will be evaluated according to WHO recommendations.
Cost of monitoring
The cost of monitoring will be evaluated from the perspective of health insurance.
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.
Full Information
NCT ID
NCT02361099
First Posted
February 3, 2015
Last Updated
June 25, 2020
Sponsor
Weprom
Collaborators
SIVAN Innovation Ldt
1. Study Identification
Unique Protocol Identification Number
NCT02361099
Brief Title
SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse
Acronym
SENTINEL
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 3, 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weprom
Collaborators
SIVAN Innovation Ldt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring by SENTINEL application
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Monitoring
Arm Type
No Intervention
Arm Description
Patients randomized to this arm will have a CT-scan every 3 months.
Intervention Type
Other
Intervention Name(s)
Monitoring by SENTINEL application
Other Intervention Name(s)
new technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of Life (QOL)
Description
The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.
Time Frame
12 month
Title
Depression
Description
Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.
Time Frame
12 month
Title
Relapse detection time
Description
The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging
Time Frame
24 month
Title
Performance Status (PS)
Description
Performance Status will be evaluated according to WHO recommendations.
Time Frame
24 month
Title
Cost of monitoring
Description
The cost of monitoring will be evaluated from the perspective of health insurance.
Time Frame
24 month
Title
Patient compliance
Description
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.
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with lung cancer (NSCLC and SCLC), histologically proven
Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
Age ≥ 18 ans
PS ≤ 2 within 15 days before enrollment
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.
Patient with an initial SENTINEL score ≤ 6
Patient with internet access and an e-mail box
Patient affiliated to a social security scheme
Patient has given its written consent before any specific procedure from protocol
Exclusion Criteria:
Patient whose disease has progressed at the end of the specific treatment
Symptomatic brain metastases
Persons deprived of liberty or under guardianship or curators
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
Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
Pregnant or breastfeeding women
Patient participating in another interventional study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice DENIS, MD
Organizational Affiliation
Centre Jean Bernard - LE MANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut de Cancerologie de l'Ouest - site Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Centre Hospitalier Général
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Centre Hospitalier Départemenal
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Institut de Cancerologie de l'Ouest - site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
12. IPD Sharing Statement
Learn more about this trial
SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse
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