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

Lung Cancer Clinical Trial

— REAL-MOOV-LUNG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934865
• Other study ID #: IC 2020-13
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: October 12, 2026

Study information

• Verified date: December 2023
• Source: Institut Curie
• Contact: Nicolas GIRARD, Pr
• Phone: 01 44 32 46 77
• Email: nicolas.girard2[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 12, 2026
• Est. primary completion date: October 12, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with lung cancer at any diagnostic stage and histology.

2. Patient willing to use the follow-up setting with Moovcare® Lung apps.

3. Age = 18 years.

4. 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).

5. Imaging tumor evaluation less than 12 weeks showing disease control (response or stability according to RECIST 1.1 criteria).

6. Patient with symptomatic score on Moovcare® Lung apps less than 7.

7. Patient (or relatives) with internet access, a personnal e-mail box and a smartphone.

8. Patient with social security affiliation.

9. Signed informed consent form.

Exclusion Criteria:

1. Patient with progression after the first evaluation of initial treatment.

2. Pregnancy and breast-feeding.

3. Patient under tutorship or guardianship.

4. Dementia, mental alteration or psychiatric pathology influencing patient consent procedure and/or protocol observance and study follow-up.

5. Patient enable to protocol follow-up for psychological, social, familial or geographical reasons.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Patients treated for their lung cancer.
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.

Locations

Country	Name	City	State
France	Ico Angers	Angers
France	Chu Argenteuil	Argenteuil
France	Centre Hospitalier Public du Cotentin	Cherbourg
France	Hôpital Forcilles	Férolles Attilly
France	Hôpital Nord-Ouest	Gleize
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	Paris
France	CHU de PAU	PAU
France	CH Annecy Genevois	Pringy
France	Clinique mutualiste de l'ESTUAIRE	Saint Nazaire
France	Institut Curie	Saint-cloud
France	Nouvel Hôpital Civil	Strasbourg
France	Hopital Robert Schumann	Vantoux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients.	Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months.	24 months
Primary	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	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
Secondary	Clinical aspects : Number of unscheduled hospitalizations.	Number of unscheduled hospitalizations.	24 months
Secondary	Clinical aspects : Duration of unscheduled hospitalizations.	Duration of unscheduled hospitalizations.	24 months
Secondary	Clinical aspects : Number of overall hospitalizations.	Number of overall hospitalizations.	24 months
Secondary	Clinical aspects : Duration of overall hospitalizations.	Number of overall hospitalizations.	24 months
Secondary	Clinical aspects : Quality of life.	Quality of life criteria with EORTC QLQ-C30 questionnaire scale.	Every 3 months until 24 months
Secondary	Clinical aspects : Overall survival over the entire follow-up.	Overall survival over the entire follow-up.	24 months
Secondary	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
Secondary	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
Secondary	Organizational aspects : Functioning and processing of alerts :	Time spent to register patients.	24 months
Secondary	Organizational aspects : Functioning and processing of alerts :	Total number of alerts, rate of alerts handled by the health care team.	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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