Psychometric Validation of the ESAS12-F (ESAS12-F)

August 30, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Centre hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients more than18 YO with advanced cancer, followed by the palliative care team, without any cognitive impairment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cancer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
Time Frame: day 1

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
validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
Time Frame: day 2

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
validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
Time Frame: day 7

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
validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability
Time Frame: day 2

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
validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability
Time Frame: day 7

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Director: Colombe TRICOU, MD, Hospices Civils de Lyon, Université Claude Bernard Lyon 1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ESAS12-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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