NSCLC Burden of Illness Study

NCT01772225 | Completed

• 1 other identifier: 116913
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer, Non-Small Cell

Keywords

Observational Retrospective; Health-related quality of life (HRQoL); Patients; Stage IB-IIIA; Burden of Illness; Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (3)

• 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.

• Determinations of the proportions of patients receiving each type of adjuvant chemotherapy and proportions receiving no adjuvant chemotherapy.

  Observation of retrospective data between 2009-2012.

• 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.

  Observation of retrospective data between 2009-2012.

Secondary Outcomes (6)

• Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy.

  Observation of retrospective data between 2009-2012.

• Determination of the proportion of patients with selected co morbidities (e.g., chronic obstructive pulmonary disease [COPD], cardiovascular disease, asthma).

  Observation of retrospective data between 2009-2012.

• Evaluation of the national cost-of-illness estimates for France, Germany, and the UK.

  Observation of retrospective data between 2009-2012.

• Determination of indirect costs incurred.

  Observation of retrospective data between 2009-2012.

• 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).

  Observation of retrospective data between 2009-2012.

Study Arms (2)

Deceased Group

Subjects in this group will include the deceased patients from each of the three countries.

Other: Data collection

Living Group

Subjects in this group will include living patients aged 18 years or older from each of the three countries.

Other: Data collection

Interventions

Data collection OTHER

Medical record abstraction form and patient survey questionnaire.

Deceased Group; Living Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• RTI Health Solutions: collaborator

Related Publications (2)

• Chouaid C, Danson S, Andreas S, Siakpere O, Benjamin L, Ehness R, Dramard-Goasdoue MH, Barth J, Hoffmann H, Potter V, Barlesi F, Price M, Chirila C, Hollis K, Sweeney C, Wolowacz S, Kaye JA, Kontoudis I. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. Lung Cancer. 2018 Oct;124:310-316. doi: 10.1016/j.lungcan.2018.07.042. Epub 2018 Aug 10.

  PMID: 30119925 DERIVED

• Andreas S, Chouaid C, Danson S, Siakpere O, Benjamin L, Ehness R, Dramard-Goasdoue MH, Barth J, Hoffmann H, Potter V, Barlesi F, Chirila C, Hollis K, Sweeney C, Price M, Wolowacz S, Kaye JA, Kontoudis I. Economic burden of resected (stage IB-IIIA) non-small cell lung cancer in France, Germany and the United Kingdom: A retrospective observational study (LuCaBIS). Lung Cancer. 2018 Oct;124:298-309. doi: 10.1016/j.lungcan.2018.06.007. Epub 2018 Jun 9.

  PMID: 29961557 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 31, 2014

Record last verified: 2014-03