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

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.

Study Overview

• Status: Completed
• Conditions: Indolent Systemic Mastocytosis; Cutaneous Mastocytosis
• Intervention / Treatment: Other: A structured interview with every patient

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

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

Patient who has indolent cutaneous or systemic mastocytosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Cristina Bulai Livideanu, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: cutaneous mastocytosis; indolent systemic mastocytosis; quality of life questionnaire in mastocytosis patient
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Hypersensitivity; Neoplasms, Connective Tissue; Immune Complex Diseases; Mastocytosis; Mastocytosis, Systemic; Mastocytosis, Cutaneous; Mastocytoma
• Other Study ID Numbers: RC31/18/0303; 2018-A02213-52 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No