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

NCT ID: NCT04934865

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2025-02-28

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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type OTHER

Patients treated for their lung cancer.

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Argenteuil

Argenteuil, , France

Site Status

Centre Hospitalier Public du Cotentin

Cherbourg, , France

Site Status

Hôpital Forcilles

Férolles-Attilly, , France

Site Status

Hôpital Nord-Ouest

Gleizé, , France

Site Status

Hopital Franco Britannique

Levallois-Perret, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Polyclinique de Limoges - Site de François CHENIEUX

Limoges, , France

Site Status

AP-HM La Timone

Marseille, , France

Site Status

Clinique Saint-George

Nice, , France

Site Status

Institut Curie

Paris, , France

Site Status

CHU de PAU

Pau, , France

Site Status

Institut Curie

Saint-Cloud, , France

Site Status

Clinique mutualiste de l'ESTUAIRE

Saint-Nazaire, , France

Site Status

Nouvel Hôpital Civil

Strasbourg, , France

Site Status

Hopital Robert Schumann

Vantoux, , France

Site Status

Countries

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France

Other Identifiers

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IC 2020-13

Identifier Type: -

Identifier Source: org_study_id

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