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

Официальное название

Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (LUNGEVITY STUDY)

Обзор

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.

Вмешательства

• Поведенческое 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).
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Baseline Clinical Characteristics [Срок оценки: At Baseline visit, on a maximum period of 12 months.]
• Aix-Marseille-University (AMU) questionnaire [Срок оценки: At inclusion, 6 and 12 months after inclusion and every year up to 5 years]
• EORTC QLQ-LC13 [Срок оценки: at inclusion, 6 and 12 months after inclusion and every year up to 5 years]
• Hospital Anxiety and Depression Scale (HAD) [Срок оценки: at inclusion, 6 and 12 months after inclusion and every year up to 5 years]
• Treatment characteristics [Срок оценки: From date of first lung cancer treatment administration up to 5 years]
• Health status [Срок оценки: At Baseline visit and up to 5 years]
• Socio-demographic characteristics [Срок оценки: At Baseline visit and up to 5 years]

Вторичные конечные точки (2)

• Progression free survival (PFS) [Срок оценки: From date of first lung cancer treatment administration up to 5 years]
• Overall Survival (OS) [Срок оценки: From date of first lung cancer treatment initiation up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 46 центров

• 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
• … и ещё 38 центров

Идентификаторы

NCT: NCT07243132 · GFPC INVESTIGATION 07-2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗