Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Safety Issue:
No
Principal Investigator
Christopher Teale
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca UK Limited, Alderley House, Alderley Park, Macclesfield SK10 4TF, Cheshire, United Kingdom, Phone: +44 1625 516549 Fax: +44 1625 518982
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NIS-ODE-DUM-2008/1
NCT ID:
NCT00721981
Start Date:
April 2009
Completion Date:
October 2009
Related Keywords:
- Lung Cancer
- Non-Small Cell Lung Cancer
- patient preference
- oncology
- chemotherapy
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Stress, Psychological