Clinical trial NCT00721981: An Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: patient preference
oncology
chemotherapy
NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
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
timeFrame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Secondary outcomes:
measure: current medical practice treatment objectives and modalities side effects
timeFrame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
measure: socioeconomic status and demographics patients' perception of their health status and treatment patient values and patient preferences
timeFrame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Löwenstein
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca UK Limited, Alderley House, Alderley Park, Macclesfield SK10 4TF, Cheshire, United Kingdom, Phone: +44 1625 516549 Fax: +44 1625 518982
name: Christopher Teale
role: STUDY_DIRECTOR
affiliation: AstraZeneca GmbH, Tinsdaler Weg 18322880, Wedel, Germany, Phone: +49 (0) 4103 708-3096 Fax: +49 (0) 4103 708-7-3096
name: Oliver Fietz, PhD
role: STUDY_CHAIR
affiliation: Thoraxklinik Heidelberg, gGmbH, Amalienstr. 5, 69126 Heidelberg, Germany, Phone: +49 (0) 6221 396-1304 Fax: +49 (0) 6221 396-1305
name: Helge Bischoff, MD
role: PRINCIPAL_INVESTIGATOR
References: