NCT04076267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 7, 2019

Last Update Submit

August 30, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Patients with cancer

Other: Tool assessing symptoms validation

Interventions

Tool assessing symptoms validationOTHER

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

Patients with cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • cognitive impairment
  • bad performance status
  • cannot read or speak French
  • no advanced cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Colombe TRICOU, MD

    Hospices Civils de Lyon, Université Claude Bernard Lyon 1

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

September 3, 2019

Study Start

July 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

FR(1)