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Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
Sponsor: Groupe Francais De Pneumo-Cancerologie
Summary
OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers. Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis \[TNM\] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC. The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
413
Start Date
2020-12-18
Completion Date
2027-06-30
Last Updated
2025-08-04
Healthy Volunteers
No
Conditions
Interventions
Quality of Life Questionnaire-Core 30 (QLQ-C30)
The HR-QoL evaluation is based on three self-assessment questionnaires distributed to the patients according to the pre-specified data collection schedule. Patients will also complete an additional questionnaire on socio-economic and occupational outcomes
Locations (34)
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France
CHU Amiens-Picardie
Amiens, France
Centre Hospitalier Universitaire
Angers, France
Centre Hospitalier d'Annecy
Annecy, France
Centre Hospitalier du Morvan
Brest, France
CHMS
Chambéry, France
Hôpital Paul d'Egine
Champigny-sur-Marne, France
Centre Hospitalier de Chauny
Chauny, France
Centre Hospitalier du Cotentin
Cherbourg, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre Hospitalier d'Elbeuf - Pneumologie
Elbeuf, France
CHD Les Oudairies
La Roche-sur-Yon, France
Hôpital Robert Boulin
Libourne, France
Centre Hospitalier Universitaire DUPUYTREN
Limoges, France
Hôpital du Scorff
Lorient, France
Centre Leon Bérard
Lyon, France
Hôpital Européen
Marseille, France
Hôpital Nord
Marseille, France
Hôpital de Meaux
Meaux, France
Centre Catalan d'Oncologie
Perpignan, France
Centre Hospitalier Intercommunal de Quimper
Quimper, France
CHU Ponchaillou
Rennes, France
Hôpital Charles Nicolle
Rouen, France
CHU La Réunion Site Nord
Saint-Denis, France
Hôpital Privé de la Loire
Saint-Etienne, France
CHU Hôpital Nord
Saint-Etienne, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
CHU La Réunion Site Sud
Saint-Pierre, France
Institut Lucien Neuwirth
Saint-Priest-en-Jarez, France
CH de Bigorre Tarbes
Tarbes, France
Hôpital d'Instruction des Armées Ste Anne
Toulon, France
CH Bretagne Atlantique
Vannes, France
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, France
Centre hospitalier Intercommunal
Villeneuve-Saint-Georges, France