Update of the EORTC QLQ-LC13 Quality of Life Questionnaire

NCT01434784 | Completed

• 1 other identifier: Koller Lung 03/2010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Cancer

Keywords

lung cancer; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Importance of quality of life issues from health care professionals' perspective

  in the course or up to three months after patients have completed therapy

Study Arms (9)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with confirmed diagnosis of lung cancer

You may qualify if:

• confirmed diagnosis of lung cancer
• informed consent
• capability to respond to a questionnaire and to follow an interview

You may not qualify if:

• no informed consent
• lack of capability to respond to a questionnaire

Sponsors & Collaborators

• Michael Koller: lead
• Hospital of Navarra: collaborator
• Oslo University Hospital: collaborator
• Medical University of Graz: collaborator
• University of Roma La Sapienza: collaborator
• National Taiwan University Hospital: collaborator
• University of Sydney: collaborator
• University of Wuerzburg: collaborator

Study Sites (1)

Center for Clinical Studies, University Hospital Regensburg

Regensburg, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Koller, PhD

  University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr., Head of Center for Clinical Studies

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 15, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)