Clinical trial NCT04076267: Psychometric Validation of the ESAS12-F
Official title: Psychometric Validation of the French Version of the Modified Edmonton Symptom Assessment Scale: The ESAS12-F.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients more than18 YO with advanced cancer, followed by the palliative care team, without any cognitive impairment

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
timeFrame: day 1
measure: validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
timeFrame: day 2
measure: validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: construct validity
timeFrame: day 7
measure: validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability
timeFrame: day 2
measure: validation of the psychometric properties of the French version of the modified Edmonton Symptom Assessment Scale, the ESAS12-F: test-retest reliability
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon, Université Claude Bernard Lyon 1
name: Colombe TRICOU, MD
role: STUDY_DIRECTOR
References: