Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hospital Anxiety and Depression scale (HAD), Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), Questionnaire Aix-Marseille-Université (AMU).
- Who it may be relevant to
- Registry conditions: Metastatic Lung Cancer, Metastatic NSCLC, Metastatic Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (LUNGEVITY STUDY)
Overview
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.
Interventions
- Behavioral 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). - Behavioral 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. - Behavioral 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.
Primary outcome measures
- Baseline Clinical Characteristics [Time frame: At Baseline visit, on a maximum period of 12 months.]
- Aix-Marseille-University (AMU) questionnaire [Time frame: At inclusion, 6 and 12 months after inclusion and every year up to 5 years]
- EORTC QLQ-LC13 [Time frame: at inclusion, 6 and 12 months after inclusion and every year up to 5 years]
- Hospital Anxiety and Depression Scale (HAD) [Time frame: at inclusion, 6 and 12 months after inclusion and every year up to 5 years]
- Treatment characteristics [Time frame: From date of first lung cancer treatment administration up to 5 years]
- Health status [Time frame: At Baseline visit and up to 5 years]
- Socio-demographic characteristics [Time frame: At Baseline visit and up to 5 years]
Secondary outcome measures (2)
- Progression free survival (PFS) [Time frame: From date of first lung cancer treatment administration up to 5 years]
- Overall Survival (OS) [Time frame: From date of first lung cancer treatment initiation up to 5 years]
Eligibility criteria
Inclusion criteria
- Patient over 18 years old
- Patients alive after more than three years from diagnosis with stage IV or Stage III NSCLC or SCLC, not treated with cytotoxic chemotherapy at the time of inclusion (the patient may be undergoing imunotherapy, targeted therapy or surveillance).
- Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance
Exclusion criteria
- Difficulties for understanding French
- Patients undergoing treatment with cytotoxic chemotherapy
- Patients under legal guardianship, under curatorship or tutorship
- Insufficient cognitive capacity to answer questions
- Inability to obtain data collection (lost to follow-up, patient's refusal for data collection)
- Patients refusing the collection of their data (an information sheet will be provided)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 46 centers
- CH du Pays d Aix — Aix-en-Provence
- CHU Angers — Angers
- Hôpital Henri Duffaut — Avignon
- CH Bastia — Bastia
- APHP Hôpital Avicennes — Bobigny
- CHU Morvan — Brest
- Hôpital Louis Pradel — Bron
- Pneumologie Centre François Baclesse — Caen
- … and 38 more centers
Identifiers
NCT: NCT07243132 · GFPC INVESTIGATION 07-2019