Assessment of Burden Disease in Patients With Mast Cell Disorders

Study Overview
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Brief Summary
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The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the patient's remaining burden. It seems possible by a longitudinal study (patient follow-up over 1 year). Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.

Detailed Description
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Mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. The release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. These symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc. In mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs. According to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Official Title
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Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,

Conditions
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Mastocytosis, Cutaneous

Intervention / Treatment
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* Behavioral: Score SMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (> 18 years old) with confirmed mast cell disorder according to international criteria Patient affiliated to social security regime Exclusion Criteria: Patient under legal protection (guardianship, curators or court order) Patient does not speak French

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 65 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| face-to-face patients<br>During this visit, the investigator will complete the SMI score. | Behavioral: Score SMI<br>* the investigator will complete the SMI score<br>|
| Email patients<br>this visit at M0 + 7d will correspond to the emailing of the Mc_QoL and Burden_MCD questionnaires completed by the patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of mast cell disorder patients | Quality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mast cell disorder patient's life quality | Quality of life is evaluated with the WHOQOL-bref. | 6 months | 
| Mast cell disorder patient's quality of life | Quality of life is evaluated with the WHOQOL-bref. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burden, quality of life, mast cell disease, work impairment