Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG
- Conditions
- Lung Cancer
- Interventions
- Device: Patients treated for their lung cancer.
- Registration Number
- NCT04934865
- Lead Sponsor
- Institut Curie
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients treated for their lung cancer and Moovcare® Lung follow-up. Patients treated for their lung cancer. -
- Primary Outcome Measures
Name Time Method Proportion of patients. 12 months Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months.
- Secondary Outcome Measures
Name Time Method Clinical aspects : Duration of unscheduled hospitalizations. 24 months Duration of unscheduled hospitalizations.
Clinical aspects : Duration of overall hospitalizations. 24 months Number of overall hospitalizations.
Organizational aspects : Time for each investigating center 24 months Calculation of the time spent to set up the protocol and the application for each investigating center.
Clinical aspects : Number of unscheduled hospitalizations. 24 months Number of unscheduled hospitalizations.
Clinical aspects : date of consultation. 24 months Interval between the date of early consultation or early scan and the date of the scheduled consultation or scan.
Clinical aspects : Number of overall hospitalizations. 24 months Number of overall hospitalizations.
Clinical aspects : Overall survival over the entire follow-up. 24 months Overall survival over the entire follow-up.
Organizational aspects : Functioning and processing of alerts : 24 months Relevant post-alert management time, as well as the number of stakeholders on the application, type of stakeholders.
Clinical aspects : Quality of life. Every 3 months until 24 months Quality of life criteria with EORTC QLQ-C30 questionnaire scale.
Organizational aspects : number of stakeholders 24 months Number of stakeholders on the application, number of stakeholders specifically recruited for the application and type of stakeholders.
Organizational aspects : Patient satisfaction. 3, 6, 12, 18 and 24 months of use of the application 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.
Organizational aspects : Satisfaction of the care teams at 6 months follow-up. 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).Organizational aspects : Patient compliance. 24 months 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.Organizational aspects : all secondary outcome measures 12 months of follow-up above criteria will be assessed at 12 months of follow-up. This analysis will be done one year after inclusion of the last patient.
Trial Locations
- Locations (14)
Hôpital Nord-Ouest
🇫🇷Gleize, France
Chu Argenteuil
🇫🇷Argenteuil, France
Centre Hospitalier Public du Cotentin
🇫🇷Cherbourg, France
Hôpital Forcilles
🇫🇷Férolles Attilly, France
Hopital Franco Britannique
🇫🇷Levallois-Perret, France
Centre Oscar Lambret
🇫🇷Lille, France
Polyclinique de Limoges - Site de François CHENIEUX
🇫🇷Limoges, France
AP-HM La Timone
🇫🇷Marseille, France
Clinique Saint-George
🇫🇷Nice, France
Institut Curie
🇫🇷Saint-cloud, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Hopital Robert Schumann
🇫🇷Vantoux, France
CHU de PAU
🇫🇷PAU, France
Clinique mutualiste de l'ESTUAIRE
🇫🇷Saint Nazaire, France