Psychometric Properties of the EORTC QLQ-LC29

NCT02745691 | Completed

• 1 other identifier: LC29_Phase4
• Study Type: observational
• Target: 523
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients diagnosed with lung cancer. Participants will be enrolled in four groups according to their primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy). According to sample size calculations the investigators will include a total of N = 450 patients, but inflating the recruitment goal is permissible.

Conditions

Lung Cancer

Keywords

quality of life; psychometric validation; international field study; patient-reported outcome (PRO)

Outcome Measures

Primary Outcomes (1)

• QLQ-LC29

  Self-reported symptoms related to lung cancer. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the past week"

  In the course of therapy or up to three months after having completed therapy

Study Arms (4)

A. Surgery

A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects)

Other: Surgery

B. Radiochemotherapy

B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy

Other: Radiochemotherapy

C. Targeted therapy

C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy

Other: Targeted therapy

D. Immunotherapy

Any new immunotherapy for lung cancer

Other: Immunotherapy

Interventions

Surgery OTHER

Thoracic surgery for lung cancer

A. Surgery

Radiochemotherapy OTHER

Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)

B. Radiochemotherapy

Targeted therapy OTHER

New targeted therapies for lung cancer

Also known as: Bevacizumab, Erlotinib, Gefitinib, and Crizotinib

C. Targeted therapy

Immunotherapy OTHER

New immunotherapies for lung cancer

D. Immunotherapy

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 histologically confirmed diagnosis of lung cancer

You may qualify if:

• histologically confirmed diagnosis of lung cancer
• no previous primary or recurrent tumour
• ability to understand the language of the questionnaire
• mental fitness to complete a questionnaire
• years of age or above
• written informed consent.-

You may not qualify if:

• no histologically confirmed diagnosis of lung cancer-
• previous primary or recurrent tumour
• not mentally fit to complete a questionnaire
• not able to understand the language of the questionnaire
• younger than 18
• refusal of informed consent.

Sponsors & Collaborators

• University Hospital Regensburg: lead

Study Sites (1)

Center for Clinical Studies, University Hospital Regensburg

Regensburg, Germany

Location

Related Publications (2)

• Koch M, Grafenstein L, Karnosky J, Schulz C, Koller M. Psychosocial Burden and Quality of Life of Lung Cancer Patients: Results of the EORTC QLQ-C30/QLQ-LC29 Questionnaire and Hornheide Screening Instrument. Cancer Manag Res. 2021 Aug 7;13:6191-6197. doi: 10.2147/CMAR.S314310. eCollection 2021.

  PMID: 34393512 DERIVED

• Koller M, Shamieh O, Hjermstad MJ, Hornslien K, Young T, Chalk T, Ioannidis G, Harle A, Johnson CD, Tomaszewski KA, Serpentini S, Pinto M, van der Weijst L, Janssens A, Morag O, Chie WC, Arraras JI, Pompili C, Jungraithmayr W, Hechtner M, Katsochi D, Muller K, Grafenstein L, Schulz C, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; EORTC Lung Cancer Group; European Society of Thoracic Surgeons. Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study. Lancet Oncol. 2020 May;21(5):723-732. doi: 10.1016/S1470-2045(20)30093-0. Epub 2020 Mar 23.

  PMID: 32213338 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative; Chemoradiotherapy; Bevacizumab; Erlotinib Hydrochloride; Gefitinib; Crizotinib; Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Aminopyridines; Pyridines; Immunomodulation; Biological Therapy

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: PRINCIPAL INVESTIGATOR
• PI Title: Head, Center of Clinical Studies

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)