Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language

Indolent Systemic Mastocytosis Clinical Trial

— Mc_QoL  

Official title:

Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632811
• Other study ID #: RC31/18/0303
• Secondary ID: 2018-A02213-52
• Status: Completed
• Start date: November 14, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015.

The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.

Description:

The first two steps of the program of linguistic translation have already been carried out under the direction and supervision of teams from Charité University, Berlin and Moxie Company. The result of these two steps is a secondary version of the Mc-QoL questionnaire in French. The last step of this adaptation process in the target language (French, France) needs to be carried out and it is the subject of this study.

The objective of this study is the French language adaptation of the Mc-QoL questionnaire in adult patients with indolent cutaneous and / or indolent systemic mastocytosis.

During this study, the second version of the Mc-QoL questionnaire in French will be evaluated on 10 adult patients, with cutaneous and / or indolent systemic mastocytosis and native in the French language. The comprehension tests will be carried out by means of the structured interviews during which the investigator will ask if the patient has had difficulties to understand the recommendations, the questionnaires, will verify the interpretation of all the items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.

Revisions to the second version of the Mc-QoL questionnaire in French will be done to rectify the problems identified in the conceptual equivalence. The result will be a third French version of the Mc-QoL questionnaire, which will be the final version.

A report on the interviews will be written in English: it will describe the number of respondents, their age, the time required to complete the questionnaire, the difficulties encountered, the solutions suggested and retained and how the third version of the questionnaire was produced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at CEREMAST, Toulouse

• Patient having given his agreement of non-opposition

Exclusion Criteria:

• Minor patient

• Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis

• Patient with no mast cell pathology

• French non-native patient

• Patient in detention or under guardianship

• Patient not affiliated with Social Security

Related Conditions & MeSH terms

• Cutaneous Mastocytosis
• Indolent Systemic Mastocytosis
• Mastocytosis

Intervention

Other:
• A structured interview with every patient
The comprehension test will be done through structured interviews in which the principal investigator will ask if the patient has had difficulty understanding the recommendations and questions, will check the interpretation of all items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The understanding of aspects of the questionnaire Mc-QoL	The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient: - the instructions	1 day
Primary	The understanding of aspects of the questionnaire Mc-QoL	The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the questions (items) and the proposed answers	1 day
Primary	The understanding of aspects of the questionnaire Mc-QoL	The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the layout of the questionnaire	1 day
Primary	The understanding of aspects of the questionnaire Mc-QoL	The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the language (words) used, if it is simple and appropriate	1 day