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Spots Global Cancer Trial Database for NSCLC Burden of Illness Study

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Trial Identification

Brief Title: NSCLC Burden of Illness Study

Official Title: A Burden-of Illness Study in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Study ID: NCT01772225

Interventions

Data collection

Study Description

Brief Summary: The aim of this observational study is to identify and quantify the humanistic and economic burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA NSCLC in three European countries (France, Germany, and the United Kingdom \[UK\]). Data collection will be conducted through patient medical record abstraction and patient survey.

Detailed Description: The study procedures will have no effect on the medical care delivered to enrolled patients. Physicians will continue to provide usual medical care to patients. There is no study intervention, and no drug or other intervention will be provided to the site as part of the study. Methodology: the study will consist of two components: * Medical record abstraction. Medical records of eligible patients (both living and deceased) will be reviewed, and data will be extracted for the study. Data collected will include patient demographic and disease characteristics, details of medical care received (including adjuvant treatment), and information about disease recurrence/progression. * Patient survey. Living patients will be asked to participate in a patient survey. Living patients who agree to participate will be administered a brief patient questionnaire to collect information that is not available in the clinical sites' medical records \[e.g., local medical care, patient out-of-pocket expenses, work loss, and health-related quality of life (HRQOL)\]. The site may exclude individual patients from the survey if site staff feel that it would be inappropriate for that individual; the study will not collect patient survey information from the families of deceased patients. Informed consent will be collected from living patients who participate in the patient survey, apart from the abstraction of their medical records. Country-specific requirements will be followed. The medical records of patients (living or deceased) with complete resection of stage IB-IIIA NSCLC between 01 August 2009 and 31 July 2012 will be identified. No vaccine or drug was administered during this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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