An Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy

Terminated

• Conditions: Non-small Cell Lung Cancer; Lung Cancer

• Registration Number: NCT00721981
• Lead Sponsor: AstraZeneca

Brief Summary

The main purpose of this study is the identification, description, and segmentation of non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment outcomes and all intermediate states of health, to obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC (stage IIIB / IV) who are in transition from 1st to 2nd line treatment, and to gain utility scores by health state derived from patients' perceived value and taken from their perspective.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Study Start: 2009-04
• Study Completion: 2009-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients suffering from non-small cell lung cancer (NSCLC) with clinical stage IIIB and IV tumours
• Patients with one chemotherapy regimen (first line treatment) (adjuvant chemotherapy following surgery is also regarded as first line treatment)
• Patients who are in transition from first to second line treatment
• Patients who signed an informed consent

Exclusion Criteria

• Chemotherapy naïve patients
• Patients ever enrolled in clinical studies treating non-small cell lung cancer (NSCLC) with chemotherapy (during 1st and 2nd line chemotherapy)
• Patients who ever had chemotherapy for an indication other than NSCLC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC stage IIb/IV who are in transition from 1st line to 2nd line treatment	once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy

Secondary Outcome Measures

Name	Time	Method
socioeconomic status and demographics patients' perception of their health status and treatment patient values and patient preferences	once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
current medical practice treatment objectives and modalities side effects	once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy

Trial Locations

Locations (1)

Research Site; 🇩🇪 Trier, Germany