Update of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
This study is currently recruiting participants.
Verified September 2011 by University Hospital Regensburg
Sponsor:
Michael Koller
Collaborators:
Hospital of Navarra
Oslo University Hospital
Medical University of Graz
University of Roma La Sapienza
National Taiwan University Hospital
University of Sydney
University of Wuerzburg
Information provided by (Responsible Party):
Michael Koller, University Hospital Regensburg
ClinicalTrials.gov Identifier:
NCT01434784
First received: September 12, 2011
Last updated: September 23, 2011
Last verified: September 2011
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Purpose
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) is considered as a standard instrument to assess the quality of life (QL) of lung cancer patients. Since its publication in 1994, major clinical advances have been made. The research objective is to develop a revised lung cancer module that (a) covers all QL aspects relevant in the context of newly available diagnostic and therapeutic options, (b) is applicable in both non-metastatic and metastatic cancers, (c) and covers QL aspects that are generally relevant for patients with lung cancer but are missing in the original module. This project will comprise the first three project phases according to the Module Development Manual (www.eortc.be/qol).
| Condition |
|---|
|
Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Update of the EORTC Questionnaire for Assessing the Quality of Life in Lung Cancer Patients (EORTC QLQ-LC13) Phases I - III |
Resource links provided by NLM:
Further study details as provided by University Hospital Regensburg:
Primary Outcome Measures:
- Importance of quality of life issues from patients' perspective [ Time Frame: in the course or up to three months after having completed therapy ] [ Designated as safety issue: No ]Importance of quality of life issues are assessed using a four-point scale (1= not at all, 2 = a little, 3 = quite a bit, 4 = very much. Only issues with a mean of > 2 are considered for inclusion in the questionnaire.
Secondary Outcome Measures:
- Importance of quality of life issues from health care professionals' perspective [ Time Frame: in the course or up to three months after patients have completed therapy ] [ Designated as safety issue: No ]Importance of quality of life issues are assessed using a four-point scale (1= not at all, 2 = a little, 3 = quite a bit, 4 = very much. Only issues with a mean of > 2 are considered for inclusion in the questionnaire.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| NSCLC, curative |
| NSCLC, palliative |
| SCLC, curative |
| SCLC, palliative |
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 with confirmed diagnosis of lung cancer
Criteria
Inclusion Criteria:
- confirmed diagnosis of lung cancer
- informed consent
- capability to respond to a questionnaire and to follow an interview
Exclusion Criteria:
- no informed consent
- lack of capability to respond to a questionnaire
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434784
Contacts
| Contact: Michael Koller, PhD | +49 941 944 ext 5630 | michael.koller@klinik.uni-regensburg.de |
Locations
| Germany | |
| Center for Clinical Studies, University Hospital Regensburg | Recruiting |
| Regensburg, Germany | |
| Contact: Koller michael.koller@klinik.uni-regensburg.de | |
Sponsors and Collaborators
Michael Koller
Hospital of Navarra
Oslo University Hospital
Medical University of Graz
University of Roma La Sapienza
National Taiwan University Hospital
University of Sydney
University of Wuerzburg
More Information
No publications provided
| Responsible Party: | Michael Koller, Prof. Dr., Head of Center for Clinical Studies, University Hospital Regensburg |
| ClinicalTrials.gov Identifier: | NCT01434784 History of Changes |
| Other Study ID Numbers: | Koller Lung 03/2010 |
| Study First Received: | September 12, 2011 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Regensburg:
|
lung cancer quality of life |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013