Back to resultsReal Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG (REAL-MOOV-LUNG)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients treated for their lung cancer.
Sponsored by
About this trial
This is an interventional other trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Ico Angers
- Chu ArgenteuilRecruiting
- Centre Hospitalier Public du CotentinRecruiting
- Hôpital ForcillesRecruiting
- Hôpital Nord-OuestRecruiting
- Hopital Franco BritanniqueRecruiting
- Centre Oscar LambretRecruiting
- Polyclinique de Limoges - Site de François CHENIEUXRecruiting
- AP-HM La TimoneRecruiting
- Clinique Saint-GeorgeRecruiting
- Institut CurieRecruiting
- CHU de PAURecruiting
- CH Annecy Genevois
- Clinique mutualiste de l'ESTUAIRERecruiting
- Institut CurieRecruiting
- Nouvel Hôpital CivilRecruiting
- Hopital Robert SchumannRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients treated for their lung cancer and Moovcare® Lung follow-up.
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients.
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months.
Proportion of patients.
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months.
Secondary Outcome Measures
Clinical aspects : date of consultation.
Interval between the date of early consultation or early scan and the date of the scheduled consultation or scan.
Clinical aspects : Number of unscheduled hospitalizations.
Number of unscheduled hospitalizations.
Clinical aspects : Duration of unscheduled hospitalizations.
Duration of unscheduled hospitalizations.
Clinical aspects : Number of overall hospitalizations.
Number of overall hospitalizations.
Clinical aspects : Duration of overall hospitalizations.
Number of overall hospitalizations.
Clinical aspects : Quality of life.
Quality of life criteria with EORTC QLQ-C30 questionnaire scale.
Clinical aspects : Overall survival over the entire follow-up.
Overall survival over the entire follow-up.
Organizational aspects : number of stakeholders
Number of stakeholders on the application, number of stakeholders specifically recruited for the application and type of stakeholders.
Organizational aspects : Time for each investigating center
Calculation of the time spent to set up the protocol and the application for each investigating center.
Organizational aspects : Functioning and processing of alerts :
Time spent to register patients.
Organizational aspects : Functioning and processing of alerts :
Total number of alerts, rate of alerts handled by the health care team.
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.
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.
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04934865
Brief Title
Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 12, 2026 (Anticipated)
Study Completion Date
October 12, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated for their lung cancer and Moovcare® Lung follow-up.
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Patients treated for their lung cancer.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients.
Description
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months.
Time Frame
24 months
Title
Proportion of patients.
Description
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical aspects : date of consultation.
Description
Interval between the date of early consultation or early scan and the date of the scheduled consultation or scan.
Time Frame
24 months
Title
Clinical aspects : Number of unscheduled hospitalizations.
Description
Number of unscheduled hospitalizations.
Time Frame
24 months
Title
Clinical aspects : Duration of unscheduled hospitalizations.
Description
Duration of unscheduled hospitalizations.
Time Frame
24 months
Title
Clinical aspects : Number of overall hospitalizations.
Description
Number of overall hospitalizations.
Time Frame
24 months
Title
Clinical aspects : Duration of overall hospitalizations.
Description
Number of overall hospitalizations.
Time Frame
24 months
Title
Clinical aspects : Quality of life.
Description
Quality of life criteria with EORTC QLQ-C30 questionnaire scale.
Time Frame
Every 3 months until 24 months
Title
Clinical aspects : Overall survival over the entire follow-up.
Description
Overall survival over the entire follow-up.
Time Frame
24 months
Title
Organizational aspects : number of stakeholders
Description
Number of stakeholders on the application, number of stakeholders specifically recruited for the application and type of stakeholders.
Time Frame
24 months
Title
Organizational aspects : Time for each investigating center
Description
Calculation of the time spent to set up the protocol and the application for each investigating center.
Time Frame
24 months
Title
Organizational aspects : Functioning and processing of alerts :
Description
Time spent to register patients.
Time Frame
24 months
Title
Organizational aspects : Functioning and processing of alerts :
Description
Total number of alerts, rate of alerts handled by the health care team.
Time Frame
24 months
Title
Organizational aspects : Functioning and processing of alerts :
Description
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.
Time Frame
24 months
Title
Organizational aspects : Functioning and processing of alerts :
Description
Relevant post-alert management time, as well as the number of stakeholders on the application, type of stakeholders.
Time Frame
24 months
Title
Organizational aspects : Patient satisfaction.
Description
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.
Time Frame
3, 6, 12, 18 and 24 months of use of the application
Title
Organizational aspects : Satisfaction of the care teams at 6 months follow-up.
Description
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).
Time Frame
6 months follow-up
Title
Organizational aspects : Patient compliance.
Description
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.
Time Frame
24 months
Title
Organizational aspects : all secondary outcome measures
Description
above criteria will be assessed at 12 months of follow-up. This analysis will be done one year after inclusion of the last patient.
Time Frame
12 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GIRARD, Pr
Phone
01 44 32 46 77
Email
nicolas.girard2@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fouzia AZZOUZ, PhD
Phone
01 47 11 23 66
Email
fouzia.azzouz@curie.fr
Facility Information:
Facility Name
Ico Angers
City
Angers
ZIP/Postal Code
44805
Country
France
Individual Site Status
Withdrawn
Facility Name
Chu Argenteuil
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure BELMONT, MD
Email
laure.belmont@ch-argenteuil.fr
First Name & Middle Initial & Last Name & Degree
Laure BELMONT, MD
Facility Name
Centre Hospitalier Public du Cotentin
City
Cherbourg
ZIP/Postal Code
50100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure KALUZINSKI, MD
Email
laure.kaluzinski@ch-cotentin.fr
First Name & Middle Initial & Last Name & Degree
Laure KALUZINSKI, MD
Facility Name
Hôpital Forcilles
City
Férolles Attilly
ZIP/Postal Code
77150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salima KALLA, MD
Email
skalla@cognacq-jay.fr
First Name & Middle Initial & Last Name & Degree
Salima KALLA, MD
Facility Name
Hôpital Nord-Ouest
City
Gleize
ZIP/Postal Code
69400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc ODIER, MD
Email
LOdier@lhopitalnordouest.fr
First Name & Middle Initial & Last Name & Degree
Luc ODIER, MD
Facility Name
Hopital Franco Britannique
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PEREZ-STAUB
Phone
0147591915
Email
nathalie.perez-staub@ihfb.org
First Name & Middle Initial & Last Name & Degree
Nathalie PEREZ-STAUB, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric DANSIN, MD
Email
e-dansin@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Eric DANSIN, MD
Facility Name
Polyclinique de Limoges - Site de François CHENIEUX
City
Limoges
ZIP/Postal Code
87039
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier ZASADNY, MD
Phone
0555454800
Email
xz@imagemed-87.com
First Name & Middle Initial & Last Name & Degree
Xavier ZASADNY, MD
Facility Name
AP-HM La Timone
City
Marseille
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent GREILLIER, PH
Phone
0491965901
Email
laurent.greillier@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Laurent GREILLIER, PH
Facility Name
Clinique Saint-George
City
Nice
ZIP/Postal Code
06100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ophélie CASSUTO, MD
Phone
0492145454
Email
drcassuto@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ophélie CASSUTO, MD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRARD, PH
Phone
0144324677
Email
nicolas.girard2@curie.fr
First Name & Middle Initial & Last Name & Degree
Nicolas GIRARD, PH
Facility Name
CHU de PAU
City
PAU
ZIP/Postal Code
64046
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Aldo RERNAULT, MD
Phone
0559724123
Email
aldo.renault@ch-pau.fr
First Name & Middle Initial & Last Name & Degree
Patrick Aldo RENAULT, MD
Facility Name
CH Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Withdrawn
Facility Name
Clinique mutualiste de l'ESTUAIRE
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry CHATELLIER, MD
Email
thierry.chatellier@hospigrandouest.fr
First Name & Middle Initial & Last Name & Degree
Thierry CHATELLIER, MD
Facility Name
Institut Curie
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Ange MASSIANI, MD
Phone
0147111519
Email
marieange.massiani@curie.fr
First Name & Middle Initial & Last Name & Degree
Marie-Ange MASSIANI, MD
Facility Name
Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand MENNECIER, MD
Phone
0369550905
Email
bertrand.mennecier@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Bretrand MENNECIER, MD
Facility Name
Hopital Robert Schumann
City
Vantoux
ZIP/Postal Code
57070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit BODBERT, MD
Email
benoit.godbert@hp-metz.fr
First Name & Middle Initial & Last Name & Degree
Benoît GODBERT, MD
12. IPD Sharing Statement
Learn more about this trial
Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG
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