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Sponsor: Groupe Francais De Pneumo-Cancerologie
Conditions: Non-Small Cell Lung Cancer
Interventions: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Countries: France
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * Pathological confirmation of NSCLC obtained from a tumor cytology or biopsy * Treatment-naïve unresectable TNM stage III NSCLC (according to the 8th TNM IASLC edition). Of note, unresectability could be due to either functional limitation or anatomical extension of the tumor. * Patient willing and able to complete collection of data via self-assessment questionnaires * Patient without any local or systemic anti-neoplastic treatment are eligible (palliative symptomatic radiotherapy is considered best supportive care) * Patients participating in other interventional or non-interventional studies can be included. Exclusion Criteria: * Early stage NSCLC initially treated locally (surgery or other) and classified as pathological TNM stage III (according to the 8th TNM IASLC edition) * At the treating physician's discretion, patient not eligible physically or psychologically to be included in a clinical trial * Inability to read and/or fill out self-assessment questionnaires * Patient unable to express opposition to data collection
- Aix-en-Provence, France
- Amiens, France
- Angers, France
- Annecy, France
- Brest, France
- Chambéry, France
- Champigny-sur-Marne, France
- Chauny, France
- Cherbourg, France
- Créteil, France
- Elbeuf, France
- La Roche-sur-Yon, France
- Libourne, France
- Limoges, France
- Lorient, France
- Lyon, France
- Marseille, France
- Marseille, France
- Meaux, France
- Perpignan, France
- Quimper, France
- Rennes, France
- Rouen, France
- Saint-Denis, France
- Saint-Etienne, France
- Saint-Etienne, France
- Saint-Nazaire, France
- Saint-Pierre, France
- Saint-Priest-en-Jarez, France
- Tarbes, France
- + 4 more on CT.gov