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

18 Years
Not Enrolling
Lung Cancer, Non-Small Cell

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Trial Information

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.

Inclusion Criteria:

Patient medical records will be screened using the following criteria:

- Patients must be aged 18 years or older at the time of first presentation with
clinical stage IB-IIIA NSCLC.

- Patients must have complete resection of pathologic stage IB-IIIA NSCLC at least 1
calendar month prior to the date of screening, according to the current
classification recommended by the International Association for the Study of Lung
Cancer (2009). The investigator/study site must have been the main care provider for
the patient during the period of treatment or management of the patient's NSCLC.

Exclusion Criteria:

- Patients who underwent wedge resection.

- Patients whose resection was less than 1 calendar month before the date of screening.
Patients who received adjuvant systemic treatment within a clinical trial if the
type of adjuvant treatment is either unknown or is not recommended by international
clinical guidelines [European Society for Medical Oncology (ESMO), National
Comprehensive Cancer Network (NCCN)].

- Patients who are lost to follow-up:

- Living patients who are no longer under the care of the site or can no longer be

- Deceased patients who were transferred to another NSCLC treatment centre before

Patients with concomitant malignancies who received treatment for other cancers at any
time during their treatment or follow-up for NSCLC.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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.

Outcome Time Frame:

Observation of retrospective data between 2009-2012.

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



UK: NHS Sheffield mREC

Study ID:




Start Date:

June 2013

Completion Date:

September 2013

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • Observational Retrospective
  • Health-related quality of life (HRQoL)
  • Patients
  • Stage IB-IIIA
  • Burden of Illness
  • Non-small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms