Update of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University Hospital Regensburg.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014