Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG

Study Overview
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Brief Summary
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Evaluation of patient's proportion, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

Detailed Description
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Primary objective of the study: The primary objective is a clinical one and is to evaluate the proportion of patients, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

Official Title
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Real Life Prospective Multicentric Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Patients treated for their lung cancer.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with lung cancer at any diagnostic stage and histology. Patient willing to use the follow-up setting with Moovcare® Lung apps. Age ≥ 18 years. Patient received anti-cancer treatment (surgery, chemotherapy, radiation (stereotaxy or not) or radio-chemotherapy association ended less than 12 weeks (Cohort 1 post-treatment); or during maintenance treatment or consolidation by chemotherapy or targeted therapy, or by immunotherapy initiated less than 12 weeks (Cohort 2 during treatment). Imaging tumor evaluation less than 12 weeks showing disease control (response or stability according to RECIST 1.1 criteria). Patient with symptomatic score on Moovcare® Lung apps less than 7. Patient (or relatives) with internet access, a personnal e-mail box and a smartphone. Patient with social security affiliation. Signed informed consent form. Exclusion Criteria: Patient with progression after the first evaluation of initial treatment. Pregnancy and breast-feeding. Patient under tutorship or guardianship. Dementia, mental alteration or psychiatric pathology influencing patient consent procedure and/or protocol observance and study follow-up. Patient enable to protocol follow-up for psychological, social, familial or geographical reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients treated for their lung cancer and Moovcare® Lung follow-up.<br> | Device: Patients treated for their lung cancer.<br>* In addition to the weekly Moovcare® Lung follow-up, patients will benefit from standard oncological follow-up at the discretion of their oncologist according to standard recommendations for 2 years. Questionnaires will be completed at different times as mentioned below on the global study scheme and Flowchart. In an active treatment situation, the pace of consultations will be adapted to the pace of treatment administration, according to standard recommendations. It may be lengthened in the absence of a clinical application or biological alert at the discretion of the investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients. | Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months. | 24 months | 
| Proportion of patients. | Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical aspects : date of consultation. | Interval between the date of early consultation or early scan and the date of the scheduled consultation or scan. | 24 months | 
| Clinical aspects : Number of unscheduled hospitalizations. | Number of unscheduled hospitalizations. | 24 months | 
| Clinical aspects : Duration of unscheduled hospitalizations. | Duration of unscheduled hospitalizations. | 24 months | 
| Clinical aspects : Number of overall hospitalizations. | Number of overall hospitalizations. | 24 months | 
| Clinical aspects : Duration of overall hospitalizations. | Number of overall hospitalizations. | 24 months | 
| Clinical aspects : Quality of life. | Quality of life criteria with EORTC QLQ-C30 questionnaire scale. | Every 3 months until 24 months | 
| Clinical aspects : Overall survival over the entire follow-up. | Overall survival over the entire follow-up. | 24 months | 
| Organizational aspects : number of stakeholders | Number of stakeholders on the application, number of stakeholders specifically recruited for the application and type of stakeholders. | 24 months | 
| Organizational aspects : Time for each investigating center | Calculation of the time spent to set up the protocol and the application for each investigating center. | 24 months | 
| Organizational aspects : Functioning and processing of alerts : | Time spent to register patients. | 24 months | 
| Organizational aspects : Functioning and processing of alerts : | Total number of alerts, rate of alerts handled by the health care team. | 24 months | 
| Organizational aspects : Functioning and processing of alerts : | Number of alerts that led to an early consultation: processing time, type of provider(s), number of alerts that led to further investigation and the type of investigation: processing time, type of provider(s), rate of alerts that led to a change in management. | 24 months | 
| Organizational aspects : Functioning and processing of alerts : | Relevant post-alert management time, as well as the number of stakeholders on the application, type of stakeholders. | 24 months | 
| Organizational aspects : Patient satisfaction. | The degree of patient satisfaction will be evaluated with a satisfaction questionnaire. A form to be filled in after 3, 6, 12, 18 and 24 months of use of the application. | 3, 6, 12, 18 and 24 months of use of the application | 
| Organizational aspects : Satisfaction of the care teams at 6 months follow-up. | Physician satisfaction: the satisfaction of all doctors involved will be evaluated with a questionnaire to be filled in (Questionnaire Satisfaction Médecins). Staff satisfaction: the satisfaction of all staff involved (coordinating nurses, secretaries or other categories of staff) will be assessed with a questionnaire to be filled in (Questionnaire Satisfaction Collaborateur). | 6 months follow-up | 
| Organizational aspects : Patient compliance. | The compliance will be evaluated by the ratio between the number of completed questionnaires and the invitation's number sent to complete them. Reasons of impossible connection (must be documented on medical records) will be subtracted from the calculation. The number of patients who voluntary abandoned the use of Moovcare® Lung medical device will be reduced considered as non-compliant. | 24 months | 
| Organizational aspects : all secondary outcome measures | above criteria will be assessed at 12 months of follow-up. This analysis will be done one year after inclusion of the last patient. | 12 months of follow-up |