Study Stopped
Low Recruitment
An Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy
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
1 other identifier
observational
120
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2009
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedDecember 10, 2010
December 1, 2010
July 23, 2008
December 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
current medical practice treatment objectives and modalities side effects
once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
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
Study Arms (1)
1
Regular treatment for non-small cell lung cancer (NSCLC)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
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
München, Germany
Research Site
Trier, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
April 1, 2009
Study Completion
October 1, 2009
Last Updated
December 10, 2010
Record last verified: 2010-12