Psychometric Properties of the EORTC QLQ-LC29

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Surgery
* Other: Radiochemotherapy
* Other: Targeted therapy
* Other: Immunotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A. Surgery<br>A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects) | Other: Surgery<br>* Thoracic surgery for lung cancer<br>|
| B. Radiochemotherapy<br>B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy | Other: Radiochemotherapy<br>* Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)<br>|
| C. Targeted therapy<br>C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy | Other: Targeted therapy<br>* New targeted therapies for lung cancer<br>* Other names: Bevacizumab, Erlotinib, Gefitinib, and Crizotinib;|
| D. Immunotherapy<br>Any new immunotherapy for lung cancer | Other: Immunotherapy<br>* New immunotherapies for lung cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, psychometric validation, international field study, patient-reported outcome (PRO)