MCD&BuDi: Assessment of Burden Disease in Patients With Mast Cell Disorders
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| face-to-face patients During this visit, the investigator will complete the SMI score. |
Behavioral: Score SMI
the investigator will complete the SMI score
|
| Email patients this visit at M0 + 7d will correspond to the emailing of the Mc_QoL and Burden_MCD questionnaires completed by the patient. |
Outcome Measures
Primary Outcome Measures
- Quality of life of mast cell disorder patients [Baseline]
Quality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life.
Secondary Outcome Measures
- Mast cell disorder patient's life quality [6 months]
Quality of life is evaluated with the WHOQOL-bref.
- Mast cell disorder patient's quality of life [12 months]
Quality of life is evaluated with the WHOQOL-bref.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cristina BULAI LIVIDEANU | Toulouse | France |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: LIVIDEANU Cristina, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/19/0354