Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated for their lung cancer and Moovcare® Lung follow-up. | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients treated for their lung cancer. | Device | 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Argenteuil | Argenteuil | 95100 | France | |||
| Centre Hospitalier Public du Cotentin |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| Cherbourg |
| 50100 |
| France |
| Hôpital Forcilles | Férolles-Attilly | 77150 | France |
| Hôpital Nord-Ouest | Gleizé | 69400 | France |
| Hopital Franco Britannique | Levallois-Perret | 92300 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Polyclinique de Limoges - Site de François CHENIEUX | Limoges | 87039 | France |
| AP-HM La Timone | Marseille | 13915 | France |
| Clinique Saint-George | Nice | 06100 | France |
| Institut Curie | Paris | 75005 | France |
| CHU de PAU | Pau | 64046 | France |
| Institut Curie | Saint-Cloud | 92210 | France |
| Clinique mutualiste de l'ESTUAIRE | Saint-Nazaire | 44600 | France |
| Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Hopital Robert Schumann | Vantoux | 57070 | France |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided