Pancreatic CancerNCT05147168
Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version in Taiwan
An observational study of Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Nov 2021to 22 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic Cancer
Who may be able to join
- 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.
Who cannot join
- 1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei County, 11217
Taipei Veterans General Hospital, +886-2-2871-2121
About this study
Official title: Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan
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
Read the detailed description
- 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.
- 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
- 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
- Conditions
- Pancreatic Cancer
- Being tested
- Questionnaire
- Keywords
- Quality of life, Psychometric Validation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start22 Nov 2021
- Primary completion22 Nov 2024 (estimated)
- Study completion22 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, PhD, Study chair, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147168
- Sponsor's protocol ID
- 2021-11-012BC
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan
- ClinicalTrials.gov ID
- NCT05147168
- Acronym / sponsor ID
- 2021-11-012BC
- Conditions
- Pancreatic Cancer
- Keywords
- Quality of life, Psychometric Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 22 Nov 2024 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
- 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
- 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic Cancer
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePsychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan | Other | – |
Primary outcome
Quality of Life (EORTC QLQ-C30 )
Time frame: baseline
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.
Quality of Life (EORTC QLQ-PAN26 )
Time frame: baseline
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.
Quality of Life (EORTC QLQ-PAN26 )
Time frame: 2nd or 3rd week after recruited
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.
Quality of Life(SF-36)
Time frame: baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Mei Chen, PhD study chair
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Ling Gao, BSN (886-932637095, wlgao@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EORTC QLQ-C30 ) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.