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Update EORTC QLQ-LC13

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital Regensburg
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: December 20, 2014
Last verified: December 2014
  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 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (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: 135
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery alone
Patients undergoing any kind surgery for lung cancer, no additional surgery, quality of life assessment with the provisional updated lung cancer module within 3 months after surgery
Surgery in combination with any other tx
Patients undergoing any kind surgery for lung cancer, additional therapy is permitted, quality of life assessment with the provisional updated lung cancer module within 3 months after surgery
Surgery (late effects)
Patients undergoing any kind surgery for lung cancer, additional therapy is permitted, quality of life assessment with the provisional updated lung cancer moduleat least 3 months after surgery and 3 months after any other active treatment
Chemotherapy alone
Patient undergoing any kind of chemotherapy for lung cancer, no additional therapy, quality of life assessment with the provisional updated lung cancer module during or up to 4 weeks after completion of therapy
Radiotherapy alone
Patient undergoing radiotherapy for lung cancer, no additional therapy, quality of life assessment with the provisional updated lung cancer module during or up to 3 months after completion of therapy
Sequential radiochemotherapy
Patient undergoing sequential radiochemotherapy for lung cancer, no surgery, no targeted therapy, quality of life assessment with the provisional updated lung cancer module during or up to 3 months after completion of therapy
Concurrent radiochemotherapy
Patient undergoing concurrent radiochemotherapy for lung cancer, no surgery, no targeted therapy, quality of life assessment with the provisional updated lung cancer module during or up to 3 months after completion of therapy
Targeted therapy alone
Patient undergoing targeted therapy for lung cancer, no surgery, no radiochemotherapy , quality of life assessment with the provisional updated lung cancer module during or up to 4 weeks after completion of therapy
Targeted therapy in combination
Patient undergoing targeted therapy for lung cancer, additional therapies permitted, quality of life assessment with the provisional updated lung cancer module during or up to 3 months after completion of therapy

Detailed Description:

The project follows the EORTC model of module development and covers the first three phases:

Phase I This phase is aimed at compiling an extensive list of quality of life issues relevant for lung cancer patients. The following sources will be used: (1) existing questionnaires on lung cancer and respiratory illnesses, (2) the literature, (3) investigator's brochures (IB) on new drugs, and (4) interviews with health care professionals and patients.

Phase II Phase I data will provide information about the issues that should be included in an improved lung cancer module. These issues are being converted into items that follow the EORTC format with four point response scales ranging from "not at all" to "very much". For the sake of consistency and whenever possible, items of the existing QLC-LC13 will be used or other items will be taken from the Item Bank that currently includes more than 6.000 items. After this stage, the procedure will be formally peer-reviewed by the EORTC QLG Module Development Committee. After approval, the provisional list of items is ready for Phase III.

Phase III The provisional lung cancer module will be pre-tested in an international group of patients with lung cancer. Patients will be first asked to fill in the QLQ-C30 and the provisional revised lung cancer module. After completing the forms, patients will be interviewed with regard to the revised lung cancer module. The interview will identify questionnaire items that patients find annoying, confusing or upsetting. A further issue is relevance: patients should indicate whether there are issues they find irrelevant or whether issues not yet included in the provisional module need to be added. The interviewer, either a physician or a study nurse, will record patients' comments on the debriefing questionnaire.

The sample matrix specifies three main groups according to primary therapy which can be either surgery, radiochemotherapy or targeted therapy.

The singular use or combination of these therapies yields nine subgroups of patients:

1.1 Surgery alone 1.2 Surgery in combination with any other therapy 1.3 Surgery (late effects) 2.1 Chemotherapy alone 2.2 Radiotherapy alone 2.3 Sequential radiochemotherapy 2.4 Concurrent radiochemotherapy 3.1 Targeted therapy alone 3.2 Targeted therapy in combination with any other therapy

The recruitment goal is n = 15 per subgroup, resulting in a total of 135 patients.

Recruitment will take place in the following study regions: English speaking countries including the United Kingdom and Australia; Northern Europe including Norway and Germany; Southern Europe including Italy and Spain; Eastern Europe, and one non-European country (e.g., Taiwan).

  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: December 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Regensburg:
lung cancer
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015