Update of the EORTC QLQ-LC13 Quality of Life Questionnaire

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

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).

Study Overview

• Status: Completed
• Conditions: Lung Cancer

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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany
    • Center for Clinical Studies, University Hospital Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with confirmed diagnosis of lung cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Michael Koller
• Collaborators: Medical University of Graz; National Taiwan University Hospital; Oslo University Hospital; University of Roma La Sapienza; University of Sydney; University of Wuerzburg; Hospital of Navarra
• Investigators: Principal Investigator: Michael Koller, PhD, University Hospital Regensburg

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Koller Lung 03/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No