A Burden-of Illness Study in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
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
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
- 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
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.
Observational Model: Cohort, Time Perspective: Retrospective
Determination of the adjuvant therapies used in routine practice in the target countries along with the durations of treatment, doses, dose reduction rates, discontinuation rates, and reasons for discontinuation.
Observation of retrospective data between 2009-2012.
GSK Clinical Trials
UK: NHS Sheffield mREC