Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study)

Condition(s) studied

Investigational drug(s) / intervention(s)

Hospital Anxiety and Depression scale (HAD): The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), giving two scores (maximum score for each = 21).

Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13): The EORTC QLQ-LC13: a 13-item lung cancer-specific questionnaire module supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (cough, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

Questionnaire Aix-Marseille-Université (AMU): Data analysis will be firstly descriptive in order to report on the quality of life of respondents. Then, in a second stage, the factors associated with quality of life will be analyzed using linear or logistic regression models depending on the nature of the variable of interest.

Study summary

The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment.

Participants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study.

They will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.

Eligibility

Primary outcome measure(s)

• Baseline Clinical Characteristics — At Baseline visit, on a maximum period of 12 months.
  Metastatic Lung Cancer Long-Terms Responders clinical characteristics: baseline patient demographics, clinical and pathological characteristics (e.g. age, medical history, comorbidities, past history of cancer, smoking status, NSCLC or SCLC characteristics)
• Aix-Marseille-University (AMU) questionnaire — At inclusion, 6 and 12 months after inclusion and every year up to 5 years
• EORTC QLQ-LC13 — at inclusion, 6 and 12 months after inclusion and every year up to 5 years
• Hospital Anxiety and Depression Scale (HAD) — at inclusion, 6 and 12 months after inclusion and every year up to 5 years
• Treatment characteristics — From date of first lung cancer treatment administration up to 5 years
  Treatment characteristics are defined by the type of treatment, the numbers of cycle and the duration of treatment.
• Health status — At Baseline visit and up to 5 years
  Health status will be evaluated using Eastern Cooperative Oncology Group performance status (PS), and collecting data new diseases, cardiovascular, diabetes, second cancers
• Socio-demographic characteristics — At Baseline visit and up to 5 years
  Socio-demographic characteristics will be evaluated based on the following data: professional, socio-family and socio-economic characteristics, education, family status, potential professional exposure(s)

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.

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