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

December 19, 2023 updated by: Institut Curie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 44805
        • Withdrawn
        • ICO Angers
      • Argenteuil, France, 95100
      • Cherbourg, France, 50100
        • Recruiting
        • Centre Hospitalier Public du Cotentin
        • Contact:
        • Principal Investigator:
          • Laure KALUZINSKI, MD
      • Férolles Attilly, France, 77150
        • Recruiting
        • Hôpital Forcilles
        • Contact:
        • Principal Investigator:
          • Salima KALLA, MD
      • Gleize, France, 69400
      • Levallois-Perret, France, 92300
        • Recruiting
        • Hopital Franco Britannique
        • Contact:
        • Principal Investigator:
          • Nathalie PEREZ-STAUB, MD
      • Lille, France, 59000
        • Recruiting
        • Centre OSCAR LAMBRET
        • Contact:
        • Principal Investigator:
          • Eric DANSIN, MD
      • Limoges, France, 87039
        • Recruiting
        • Polyclinique de Limoges - Site de François CHENIEUX
        • Contact:
        • Principal Investigator:
          • Xavier ZASADNY, MD
      • Marseille, France, 13915
        • Recruiting
        • AP-HM La Timone
        • Contact:
        • Principal Investigator:
          • Laurent GREILLIER, PH
      • Nice, France, 06100
        • Recruiting
        • Clinique Saint-George
        • Contact:
        • Principal Investigator:
          • Ophélie CASSUTO, MD
      • PAU, France, 64046
        • Recruiting
        • CHU de PAU
        • Contact:
        • Principal Investigator:
          • Patrick Aldo RENAULT, MD
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Nicolas GIRARD, PH
      • Pringy, France, 74374
        • Withdrawn
        • Ch Annecy Genevois
      • Saint Nazaire, France, 44600
      • Saint-cloud, France, 92210
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Marie-Ange MASSIANI, MD
      • Strasbourg, France, 67091
      • Vantoux, France, 57070
        • Recruiting
        • Hopital Robert Schumann
        • Contact:
        • Principal Investigator:
          • Benoît GODBERT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients treated for their lung cancer and Moovcare® Lung follow-up.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients.
Time Frame: 24 months
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months.
24 months
Proportion of patients.
Time Frame: 12 months
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical aspects : date of consultation.
Time Frame: 24 months
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.
Time Frame: 24 months
Number of unscheduled hospitalizations.
24 months
Clinical aspects : Duration of unscheduled hospitalizations.
Time Frame: 24 months
Duration of unscheduled hospitalizations.
24 months
Clinical aspects : Number of overall hospitalizations.
Time Frame: 24 months
Number of overall hospitalizations.
24 months
Clinical aspects : Duration of overall hospitalizations.
Time Frame: 24 months
Number of overall hospitalizations.
24 months
Clinical aspects : Quality of life.
Time Frame: Every 3 months until 24 months
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.
Time Frame: 24 months
Overall survival over the entire follow-up.
24 months
Organizational aspects : number of stakeholders
Time Frame: 24 months
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
Time Frame: 24 months
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 Frame: 24 months
Time spent to register patients.
24 months
Organizational aspects : Functioning and processing of alerts :
Time Frame: 24 months
Total number of alerts, rate of alerts handled by the health care team.
24 months
Organizational aspects : Functioning and processing of alerts :
Time Frame: 24 months
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 :
Time Frame: 24 months
Relevant post-alert management time, as well as the number of stakeholders on the application, type of stakeholders.
24 months
Organizational aspects : Patient satisfaction.
Time Frame: 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.
3, 6, 12, 18 and 24 months of use of the application
Organizational aspects : Satisfaction of the care teams at 6 months follow-up.
Time Frame: 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.
Time Frame: 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.
24 months
Organizational aspects : all secondary outcome measures
Time Frame: 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.
12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

October 12, 2026

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2020-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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