NCT05147168

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 22, 2021

Last Update Submit

November 12, 2023

Conditions

Pancreatic Cancer

Keywords

Quality of lifePsychometric Validation

Outcome Measures

Primary Outcomes (4)

  • 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'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.

    baseline

  • 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'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.

    baseline

  • 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'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.

    2nd or 3rd week after recruited

  • 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'α was 0.57.

    baseline

Interventions

QuestionnaireOTHER

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic Cancer

You may qualify if:

  • Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese.
  • Pancreatic Cancer patients(stage I.II.III.IV)
  • The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

You may not qualify if:

  • \. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei County, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hui-Mei Chen, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY CHAIR

Central Study Contacts

Wei-Ling Gao, BSN

CONTACT

886-932637095wlgao@vghtpe.gov.tw

Hui-Mei Chen, PhD

CONTACT

886-2-28227101#3139alice@ntunhs.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 7, 2021

Study Start

November 22, 2021

Primary Completion

November 22, 2024

Study Completion

November 22, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 12 months and ending 36 months following article publication
Access Criteria
Researchers who provide a methodologically sound proposal and receive the authors consent

Locations

TW(1)