Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
523 participants
OBSERVATIONAL
2016-04-01
2018-09-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A. Surgery
A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects)
Surgery
Thoracic surgery for lung cancer
B. Radiochemotherapy
B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy
Radiochemotherapy
Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
C. Targeted therapy
C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy
Targeted therapy
New targeted therapies for lung cancer
D. Immunotherapy
Any new immunotherapy for lung cancer
Immunotherapy
New immunotherapies for lung cancer
Interventions
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Surgery
Thoracic surgery for lung cancer
Radiochemotherapy
Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
Targeted therapy
New targeted therapies for lung cancer
Immunotherapy
New immunotherapies for lung cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital Regensburg
OTHER
Responsible Party
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Michael Koller
Head, Center of Clinical Studies
Principal Investigators
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Michael Koller, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Regensburg
Locations
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Center for Clinical Studies, University Hospital Regensburg
Regensburg, , Germany
Countries
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References
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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.
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.
Other Identifiers
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LC29_Phase4
Identifier Type: -
Identifier Source: org_study_id