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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05147168
Other study ID # 2021-11-012BC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2021
Est. completion date November 22, 2024

Study information

Verified date November 2023
Source Taipei Veterans General Hospital, Taiwan
Contact Wei-Ling Gao, BSN
Phone 886-932637095
Email wlgao@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date November 22, 2024
Est. primary completion date November 22, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese. 2. Pancreatic Cancer patients(stage I.II.III.IV) 3. The subject who agrees and is willing to participate in the research after explaining the purpose of the research. Exclusion Criteria: 1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei county

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life (EORTC QLQ-C30 ) 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'a 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. baseline
Primary Quality of Life (EORTC QLQ-PAN26 ) 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'a 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. baseline
Primary Quality of Life (EORTC QLQ-PAN26 ) 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'a 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. 2nd or 3rd week after recruited
Primary Quality of Life(SF-36) 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'a was 0.57. baseline
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