Clinical trial NCT04934865: Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients.
timeFrame: 24 months
measure: Proportion of patients.
timeFrame: 12 months
Secondary outcomes:
measure: Clinical aspects : date of consultation.
timeFrame: 24 months
measure: Clinical aspects : Number of unscheduled hospitalizations.
timeFrame: 24 months
measure: Clinical aspects : Duration of unscheduled hospitalizations.
timeFrame: 24 months
measure: Clinical aspects : Number of overall hospitalizations.
timeFrame: 24 months
measure: Clinical aspects : Duration of overall hospitalizations.
timeFrame: 24 months
measure: Clinical aspects : Quality of life.
timeFrame: Every 3 months until 24 months
measure: Clinical aspects : Overall survival over the entire follow-up.
timeFrame: 24 months
measure: Organizational aspects : number of stakeholders
timeFrame: 24 months
measure: Organizational aspects : Time for each investigating center
timeFrame: 24 months
measure: Organizational aspects : Functioning and processing of alerts :
timeFrame: 24 months
measure: Organizational aspects : Functioning and processing of alerts :
timeFrame: 24 months
measure: Organizational aspects : Functioning and processing of alerts :
timeFrame: 24 months
measure: Organizational aspects : Functioning and processing of alerts :
timeFrame: 24 months
measure: Organizational aspects : Patient satisfaction.
timeFrame: 3, 6, 12, 18 and 24 months of use of the application
measure: Organizational aspects : Satisfaction of the care teams at 6 months follow-up.
timeFrame: 6 months follow-up
measure: Organizational aspects : Patient compliance.
timeFrame: 24 months
measure: Organizational aspects : all secondary outcome measures
timeFrame: 12 months of follow-up
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Chu Argenteuil
city: Cherbourg
country: France
facility: Centre Hospitalier Public du Cotentin
city: Férolles Attilly
country: France
facility: Hôpital Forcilles
city: Gleize
country: France
facility: Hôpital Nord-Ouest
city: Levallois-Perret
country: France
facility: Hopital Franco Britannique
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Polyclinique de Limoges - Site de François CHENIEUX
city: Marseille
country: France
facility: AP-HM La Timone
city: Nice
country: France
facility: Clinique Saint-George
city: Paris
country: France
facility: Institut Curie
city: PAU
country: France
facility: CHU de PAU
city: Saint Nazaire
country: France
facility: Clinique mutualiste de l'ESTUAIRE
city: Saint-cloud
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Vantoux
country: France
facility: Hopital Robert Schumann
Study officials:
References: