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

NCT04934865 | Completed

• 1 other identifier: IC 2020-13
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 15

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Clinical aspects : date of consultation.

  24 months

• Clinical aspects : Number of unscheduled hospitalizations.

  24 months

• Clinical aspects : Duration of unscheduled hospitalizations.

  24 months

• Clinical aspects : Number of overall hospitalizations.

  24 months

• Clinical aspects : Duration of overall hospitalizations.

  24 months

Study Arms (1)

Patients treated for their lung cancer and Moovcare® Lung follow-up.

OTHER

Device: Patients treated for their lung cancer.

Interventions

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.

Patients treated for their lung cancer and Moovcare® Lung follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (15)

Chu Argenteuil

Argenteuil, 95100, France

Location

Centre Hospitalier Public du Cotentin

Cherbourg, 50100, France

Location

Hôpital Forcilles

Férolles-Attilly, 77150, France

Location

Hôpital Nord-Ouest

Gleizé, 69400, France

Location

Hopital Franco Britannique

Levallois-Perret, 92300, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Polyclinique de Limoges - Site de François CHENIEUX

Limoges, 87039, France

Location

AP-HM La Timone

Marseille, 13915, France

Location

Clinique Saint-George

Nice, 06100, France

Location

Institut Curie

Paris, 75005, France

Location

CHU de PAU

Pau, 64046, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Clinique mutualiste de l'ESTUAIRE

Saint-Nazaire, 44600, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Hopital Robert Schumann

Vantoux, 57070, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 22, 2021
• Study Start: October 7, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: 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).

Locations

FR (15)