NSCLC Burden of Illness Study (LuCaBIS)

This study has been completed.
Sponsor:
Collaborator:
RTI Health Solutions
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01772225
First received: January 17, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lung Cancer, Non-Small Cell
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Burden-of Illness Study in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Determinations of the proportions of patients receiving each type of adjuvant chemotherapy and proportions receiving no adjuvant chemotherapy. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Determination of the level of medical resource utilization and the direct healthcare costs of managing these patients during adjuvant treatment, prior to disease recurrence/progression, and post disease recurrence/progression. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Determination of the proportion of patients with selected co morbidities (e.g., chronic obstructive pulmonary disease [COPD], cardiovascular disease, asthma). [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Evaluation of the national cost-of-illness estimates for France, Germany, and the UK. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Determination of indirect costs incurred. [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Determination of the effect of the disease on Health related quality of life (HRQOL) based on EuroQol 5 Dimensions quality-of-life questionnaire (EQ-5D). [ Time Frame: Observation of retrospective data between 2009-2012. ] [ Designated as safety issue: No ]
  • Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively. [ Time Frame: Between 01 Aug 2009 and 31 July 2012. ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: September 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Deceased Group
Subjects in this group will include the deceased patients from each of the three countries.
Other: Data collection
Medical record abstraction form and patient survey questionnaire.
Living Group
Subjects in this group will include living patients aged 18 years or older from each of the three countries.
Other: Data collection
Medical record abstraction form and patient survey questionnaire.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients (living or deceased) with complete resection (no residual disease) of stage IB-IIIA NSCLC.

Criteria

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 contacted.
    • Deceased patients who were transferred to another NSCLC treatment centre before death.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772225

Sponsors and Collaborators
GlaxoSmithKline
RTI Health Solutions
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01772225     History of Changes
Other Study ID Numbers: 116913
Study First Received: January 17, 2013
Last Updated: March 27, 2014
Health Authority: UK: NHS Sheffield mREC
France: CCTRIS, CNOM & CNIL
Germany: HEC Hessen

Keywords provided by GlaxoSmithKline:
Observational Retrospective
Health-related quality of life (HRQoL)
Patients
Stage IB-IIIA
Burden of Illness
Non-small Cell Lung Cancer (NSCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014