Non-small Cell Lung Cancer Clinical Trial
Official title:
Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.
The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).
This is a cross-sectional, non-interventional, European (France and Belgium), multicentric
prevalence study, conducted on a representative population of 500 patients with NSCLC, to
assess the frequency and the management of cachexia and associated symptoms.
The study will be conducted in accordance with the professional code of ethics and the good
epidemiological practices guidelines developed by the ADELF (the Association of
French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the
drafting of reports and publications related to the study.
The information will be collected during a single visit to the oncologist/lung specialist as
part of the usual patient management of his/her lung cancer. The physician will explain the
purpose of the study to the patient with an information form specific to the study and will
inform him/her of the option to refuse or withdraw from participation. The patient
information form in France or a specific consent form in Belgium will be signed by the
patient and a copy will be given to him/her (the original will be kept by the physician).
This study does not require any additional specific data. Data will come from the medical
file and from the routine disease management. Furthermore, the following self-completion
questionnaires will be proposed to patients: Visual analogue scale for dietary intake
(dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia
(Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT]
questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ,
International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be
collected for assessment of skeletal muscle mass index at L3.
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