Psychometric Properties of the EORTC QLQ-LC29
An International Phase 4 Field Study for Analyzing the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Lung Cancer (EORTC QLQ-LC29)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background The EORTC QLQ-C30 assesses quality of life of cancer patients and comprises 30 items that are grouped in five functional scales (physical, role, cognitive, emotional and social), one scale to rate global health and quality of life, three multi-item symptom scales (fatigue, nausea and vomiting, pain) and five single symptom items (dyspnoea, insomnia, appetite loss, constipation and diarrhea), one item assessing perceived financial impact of disease and treatment.
The updated lung cancer module, the QLQ-LC29, is a module to be used in conjunction with the QLQ-C30 for the assessment of specific aspects of quality of life in patients with lung cancer. All items are accompanied by the classic EORTC four-point Likert response scale with the labels 1 "not at all", 2 "a little", 3 "quite a bit", and 4 "very much". The time frame is the past week ("Please indicate the extent to which you have experienced these symptoms or problems during the past week").
Eligibility Patients are eligible for this study if they have a histologically confirmed diagnosis of lung cancer, are able to understand the language of the questionnaire, are mentally fit to complete the questionnaire, and have provided written informed consent.
Sampling matrix Participants will be enrolled in four groups according to their primary therapy: A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy. Various combinations of therapies are possible, resulting in a total of eight subgroups: A.1 Surgery alone and/or before any adjuvant therapy, A.2 Surgery (late effects), B.1 Chemotherapy alone, B.2 Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent radiochemotherapy, C.1 Targeted therapy alone, C.2 Targeted therapy in combination with any other therapy, D. Immunotherapy.
Procedure Patients are informed about the goal of the study. After granting informed consent, patients fill in the self-administered paper version of the EORTC QLQ-C30 plus the new lung module QLQ-LC29. Their physicians provide the clinical documentation. A subsample of the patients will fill in the questionnaires at a second time point two to four weeks later.
Sample size According to sample size calculations we will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Statistical analyses Scale structure will be analysed by confirmatory factor analyses, and backed by classical test theory (convergent/discriminant validity). Reliability will be calculated by means of Cronbach's alpha (internal consistency) and intra-class coefficient (ICC, test-retest reliability). Sensitivity of the module will be assessed by means of known group differences (Karnofsky Performance Status). Responsiveness to change over time will take into account differences between the second and first assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Regensburg, Germany
- Center for Clinical Studies, University Hospital Regensburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 18 years of age or above
- written informed consent.-
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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A. Surgery
A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects)
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Thoracic surgery for lung cancer
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B. Radiochemotherapy
B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy
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Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
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C. Targeted therapy
C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy
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New targeted therapies for lung cancer
Other Names:
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D. Immunotherapy
Any new immunotherapy for lung cancer
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New immunotherapies for lung cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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QLQ-LC29
Time Frame: In the course of therapy or up to three months after having completed therapy
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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"
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In the course of therapy or up to three months after having completed therapy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Koller, PhD, University Hospital Regensburg
Publications and helpful links
General Publications
- Koch M, Gräfenstein 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC29_Phase4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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