NSCLC Burden of Illness Study (LuCaBIS)

• ClinicalTrials.gov Identifier: NCT01772225
• Recruitment Status: Completed
• First Posted: January 21, 2013
• Last Update Posted: March 31, 2014
• Sponsor: GlaxoSmithKline
• Collaborator: RTI Health Solutions
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: January 17, 2013
• First Posted Date: January 21, 2013
• Last Update Posted Date: March 31, 2014
• Study Start Date: September 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2013)

• 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. ]
• 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. ]
• 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. ]

Original Primary Outcome Measures (submitted: January 17, 2013)

• What adjuvant therapies are used in routine practice in the target countries? What are the durations of treatment, doses, dose reduction rates, discontinuation rates, and reasons for discontinuation? [ Time Frame: Observation of retrospective data between 2009-2012 abstracted during a 5 month period in 2013. ]
• What proportions of patients receive each type of adjuvant chemotherapy and what proportion receive no adjuvant chemotherapy? [ Time Frame: Observation of retrospective data between 2009-2012. ]
• What is the level of medical resource utilisation, and what are the direct health care 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. ]

Current Secondary Outcome Measures (submitted: January 24, 2013)

• Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy. [ Time Frame: 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). [ Time Frame: Observation of retrospective data between 2009-2012. ]
• Evaluation of the national cost-of-illness estimates for France, Germany, and the UK. [ Time Frame: Observation of retrospective data between 2009-2012. ]
• Determination of indirect costs incurred. [ Time Frame: 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). [ Time Frame: Observation of retrospective data between 2009-2012. ]
• 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. ]

Original Secondary Outcome Measures (submitted: January 17, 2013)

• Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy. [ Time Frame: Observation of retrospective data between 2009-2012. ]
• 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. ]
• Evaluation of the national cost-of-illness estimates for France, Germany, and the UK. [ Time Frame: Observation of retrospective data between 2009-2012. ]
• Determination of indirect costs incurred. [ Time Frame: Observation of retrospective data between 2009-2012. ]
• Determination of the effect of the disease on Health related quality of life (HRQOL) EuroQol 5 Dimensions quality-of-life questionnaire (EQ-5D)? [ Time Frame: Observation of retrospective data between 2009-2012. ]
• Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively. [ Time Frame: 1 month after the date of surgical resection through to the end of the medical record (between 01 Aug 2009 and 31 July 2012). ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients (living or deceased) with complete resection (no residual disease) of stage IB-IIIA NSCLC.
• Condition: Lung Cancer, Non-Small Cell

Intervention

Other: Data collection

Medical record abstraction form and patient survey questionnaire.

Study Groups/Cohorts

• Deceased Group
  Subjects in this group will include the deceased patients from each of the three countries.
  Intervention: Other: Data collection
• Living Group
  Subjects in this group will include living patients aged 18 years or older from each of the three countries.
  Intervention: Other: Data collection

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2014): 1
• Original Estimated Enrollment (submitted: January 17, 2013): 900
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01772225
• Other Study ID Numbers: 116913
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: RTI Health Solutions

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: March 2014