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

Lung Cancer Clinical Trial

Official title:

A Non-interventional Study for Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy. With Special Focus on Patients Who Are in Transition From First Line to Second Line Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00721981
• Other study ID #: NIS-ODE-DUM-2008/1
• Status: Terminated
• Phase: N/A
• First received: July 23, 2008
• Last updated: December 9, 2010
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Essen
Germany	Research Site	Heidelberg
Germany	Research Site	Hemer
Germany	Research Site	Karlsruhe
Germany	Research Site	Löwenstein
Germany	Research Site	Munchen
Germany	Research Site	Trier

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	current medical practice treatment objectives and modalities side effects		once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy	No
Secondary	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	No