Psychometric Properties of the EORTC QLQ-LC29

Completed

• Conditions: Lung Cancer
• Interventions: Other: Targeted therapy; Other: Surgery; Other: Immunotherapy; Other: Radiochemotherapy

• Registration Number: NCT02745691
• Lead Sponsor: University Hospital Regensburg

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.

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 Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-17
• Study First Posted: 2016-04-20
• Primary Completion: 2018-09-26
• Study Completion: 2018-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C. Targeted therapy	Targeted therapy	C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy
A. Surgery	Surgery	A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects)
D. Immunotherapy	Immunotherapy	Any new immunotherapy for lung cancer
B. Radiochemotherapy	Radiochemotherapy	B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy

Primary Outcome Measures

Name	Time	Method
QLQ-LC29	In the course of therapy or up to three months after having completed therapy	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"

Trial Locations

Locations (1)

Center for Clinical Studies, University Hospital Regensburg; 🇩🇪 Regensburg, Germany