NSCLC Burden of Illness Study

Lung Cancer, Non-Small Cell Clinical Trial

— LuCaBIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772225
• Other study ID #: 116913
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: March 27, 2014
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: NHS Sheffield mRECFrance: CCTRIS, CNOM & CNILGermany: HEC Hessen
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Lung Neoplasms

Intervention

Other:
• Data collection
Medical record abstraction form and patient survey questionnaire.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	RTI Health Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy.		Observation of retrospective data between 2009-2012.	No
Secondary	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.	No
Secondary	Evaluation of the national cost-of-illness estimates for France, Germany, and the UK.		Observation of retrospective data between 2009-2012.	No
Secondary	Determination of indirect costs incurred.		Observation of retrospective data between 2009-2012.	No
Secondary	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.	No
Secondary	Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively.		Between 01 Aug 2009 and 31 July 2012.	No