An Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | July 23, 2008 | ||||||||||||
| Last Updated Date | December 9, 2010 | ||||||||||||
| Start Date ICMJE | April 2009 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00721981 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | 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 ICMJE | 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 | ||||||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | 1
Regular treatment for non-small cell lung cancer (NSCLC) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||||||
| Completion Date | October 2009 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00721981 | ||||||||||||
| Other Study ID Numbers ICMJE | NIS-ODE-DUM-2008/1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Chris Teale, Director Global Pricing & Market Access (Oncology), AstraZeneca UK Limited | ||||||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||||||
| Verification Date | December 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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