Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan

Questionnaire

Wei-Ling Gao, BSN

Hui-Mei Chen, PhD

Taipei Veterans General Hospital

This study will investigate the reliability and validity of Chinese version of the quality of life scale in EORTC QLQ-PAN26 and EORTC QLQ-C30 on pancreatic cancer patients in Taiwan

1. Verify the reliability and validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the chinese version of the EORTC QLQ-PAN26 Quality of Life Scale.
2. Verify the construct validity of the Chinese version of the EORTC QLQ-PAN26 Quality of Life Scale, perform factor analysis, test-retest reliability, and known group validity
3. Verify the criterion related validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the SF-36 Quality of Life Scale

Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version in Taiwan

Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales：functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

This scale was evaluated by self-assessment of various clinical problems for a month.The SF-36 included eight subscales.The reliability and validity of Cronbach'α was 0.57.

Taipei Veterans General Hospital, Taiwan

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Bevacizumab

Immunomodulating Agents

Crizotinib

Erlotinib Hydrochloride

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

Surgery

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

Radiochemotherapy

Targeted therapy

Immunotherapy

Michael Koller, PhD

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.

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.

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)

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"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version in Taiwan	NCT05147168	Pancreatic Canc...	Questionnaire	20 Years - 80 Years	Taipei Veterans General Hospital, Taiwan
Psychometric Properties of the EORTC QLQ-LC29	NCT02745691	Lung Cancer	Surgery Radiochemothera... Targeted therap... Immunotherapy	18 Years -	University Hospital Regensburg

Spots Global Cancer Trial Database for psychometric validation