Psychometric Validation of the ESAS12-F

Cancer Clinical Trial

— ESAS12-F  

Official title:

Psychometric Validation of the French Version of the Modified Edmonton Symptom Assessment Scale: The ESAS12-F.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04076267
• Other study ID #: ESAS12-F
• Status: Active, not recruiting
• Start date: July 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessing symptoms of patients with cancer should be a priority for the physicians to improve their quality of life. The Edmonton Symptom Assessment Scale (ESAS) is a common tool, easy to complete and to analyse. Originally, it has been validated in English with 9 common symptoms. But a new version with 12 commons symptoms and some explanations has been created. This modified version has been translated in French, and the transcultural validation has been done. But the psychometreic validation has not been validated yet.

The primary objective is to validate the psychometric properties of this new version in French.

To validate the tool, we will compare the ESAS12-F to the European Organization for research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) which assesses common symptoms for patients with cancer, which is validated in French, but which is longer and more difficult to complete and to analyse. the patient will complete the ESAS 12-F and the EORTC QLQ-C30 at day 1, then the ESAS12-F at day 2, and the ESAS12-F and the EORTC QLQ-C30 at day 7.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• more than 18YO

• with advanced cancer

• followed but the palliative care team of the Centre Hospitalier Lyon Sud

• without any cognitive impairment

• can read and speak French

Exclusion Criteria:

• cognitive impairment

• bad performance status

• cannot read or speak French

• no advanced cancer

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Tool assessing symptoms validation
Comparison between 2 tools evaluating the symptoms of patients with advanced cancer: the ESAS12-F and the EORTC QLQ C30 to assess if the ESAS12-F well evaluates the symptoms and if it is easy to complete. The objective is to validate the ESAS12-F, which is easier and shorter than the well validated EORTC QLQ C30

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity	The validation of the French version of the modified ESAS scale will be made by assessing the following metrological properties: validity (criterion validity and construct validity) : Criterion validity will be established against the EORTC QLQ-C30 scale using correlation coefficient for each item. It will be assessed at Day 1 and Day 7. Construct validity will be assessed by a principal component analysis (PCA) an exploratory factor analysis (EFA) and then a confirmatory analysis (CFA) on an independent sample.	day 1
Primary	validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity	The validation of the French version of the modified ESAS scale will be made by assessing the following metrological properties: validity (criterion validity and construct validity) : Criterion validity will be established against the EORTC QLQ-C30 scale using correlation coefficient for each item. It will be assessed at Day 1 and Day 7. Construct validity will be assessed by a principal component analysis (PCA) an exploratory factor analysis (EFA) and then a confirmatory analysis (CFA) on an independent sample.	day 2
Primary	validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity	The validation of the French version of the modified ESAS scale will be made by assessing the following metrological properties: validity (criterion validity and construct validity) : Criterion validity will be established against the EORTC QLQ-C30 scale using correlation coefficient for each item. It will be assessed at Day 1 and Day 7. Construct validity will be assessed by a principal component analysis (PCA) an exploratory factor analysis (EFA) and then a confirmatory analysis (CFA) on an independent sample.	day 7
Primary	validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability	The validation of the French version of the modified ESAS scale will be made by assessing the following metrological properties: reliability (internal consistency and test-retest reliability) : Internal consistency will be checked using Cronbach's alpha coefficient or a more adequate coefficient whenever the former is not applicable. Test-retest reliability will be checked using the intra-class correlation coefficient. It will be assessed at Day 2 and Day 7.	day 2
Primary	validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability	The validation of the French version of the modified ESAS scale will be made by assessing the following metrological properties: reliability (internal consistency and test-retest reliability) : Internal consistency will be checked using Cronbach's alpha coefficient or a more adequate coefficient whenever the former is not applicable. Test-retest reliability will be checked using the intra-class correlation coefficient. It will be assessed at Day 2 and Day 7.	day 7