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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00721981

Purpose

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.

Condition
Lung Cancer Non-small Cell Lung Cancer

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

current medical practice treatment objectives and modalities side effects [ Time Frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy ] [ Designated as safety issue: No ]
socioeconomic status and demographics patients' perception of their health status and treatment patient values and patient preferences [ Time Frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2009
Study Completion Date:	October 2009

Groups/Cohorts
1 Regular treatment for non-small cell lung cancer (NSCLC)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients suffering from non-small cell lung cancer (NSCLC) (stage IIIb and IV) undergoing chemotherapy, who are in transition from 1st to 2nd line treatment.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721981

Locations

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, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Christopher Teale	AstraZeneca UK Limited, Alderley House, Alderley Park, Macclesfield SK10 4TF, Cheshire, United Kingdom, Phone: +44 1625 516549 Fax: +44 1625 518982
Study Chair:	Oliver Fietz, PhD	AstraZeneca GmbH, Tinsdaler Weg 18322880, Wedel, Germany, Phone: +49 (0) 4103 708-3096 Fax: +49 (0) 4103 708-7-3096
Principal Investigator:	Helge Bischoff, MD	Thoraxklinik Heidelberg, gGmbH, Amalienstr. 5, 69126 Heidelberg, Germany, Phone: +49 (0) 6221 396-1304 Fax: +49 (0) 6221 396-1305

More Information

No publications provided

Responsible Party:	Chris Teale, Director Global Pricing & Market Access (Oncology), AstraZeneca UK Limited
ClinicalTrials.gov Identifier:	NCT00721981 History of Changes
Other Study ID Numbers:	NIS-ODE-DUM-2008/1
Study First Received:	July 23, 2008
Last Updated:	December 9, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

patient preference
oncology
chemotherapy
NSCLC

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Stress, Psychological
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 09, 2012