Update of the EORTC QLQ-LC13 Quality of Life Questionnaire

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434784
• Other study ID #: Koller Lung 03/2010
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: June 8, 2017
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2017
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Germany	Center for Clinical Studies, University Hospital Regensburg	Regensburg

Sponsors (8)

Lead Sponsor	Collaborator
Michael Koller	Hospital of Navarra, Medical University of Graz, National Taiwan University Hospital, Oslo University Hospital, University of Roma La Sapienza, University of Sydney, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Importance of quality of life issues from patients' perspective	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.	in the course or up to three months after having completed therapy
Secondary	Importance of quality of life issues from health care professionals' perspective	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.	in the course or up to three months after patients have completed therapy