Psychometric Validation of the ESAS12-F

NCT ID: NCT04076267

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cancer

Tool assessing symptoms validation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colombe TRICOU, MD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon, Université Claude Bernard Lyon 1

Locations

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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ESAS12-F

Identifier Type: -

Identifier Source: org_study_id

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