Metastatic Lung Cancer, Metastatic NSCLC, Metastatic Small Cell Lung Cancer
Conditions
Keywords
long-terms responders, Mestastatic Lung Cancer, Metastatic NSCLC, Metastatic small cell lung cancer
Brief 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.
Interventions
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).
BEHAVIORALQuality 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.
BEHAVIORALQuestionnaire 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.
Sponsors
GFPC Investigation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of first lung cancer treatment initiation up to 5 years | Overall Survival is defined as the length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive. |
| Progression free survival (PFS) | From date of first lung cancer treatment administration up to 5 years | PFS is defined as the length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse. PFS will be assessed by local review, as per the current practice at site. |
Countries
France
Contacts
Primary ContactAlice MOGENET
Backup ContactSoizic FERLANDIN
Outcome results
None listed