Assessment of Burden Disease in Patients With Mast Cell Disorders
MCD&BuDi
Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2020
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedNovember 4, 2020
November 1, 2020
1 year
June 16, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mast cell disorder patient's life quality
6 months
Mast cell disorder patient's quality of life
12 months
Study Arms (2)
face-to-face patients
During this visit, 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.
Interventions
Eligibility Criteria
Prospective, descriptive study, both transversal and longitudinal, open, monocentric, performed in 200 patients with mast cell disease and follow-up at the CEREMAST Toulouse
You may qualify if:
- Adult patient (\> 18 years old) with confirmed mast cell disorder according to international criteria
- Patient affiliated to social security regime
You may not qualify if:
- Patient under legal protection (guardianship, curators or court order)
- Patient does not speak French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cristina BULAI LIVIDEANU
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LIVIDEANU Cristina, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
November 4, 2020
Study Start
January 28, 2020
Primary Completion
January 28, 2021
Study Completion
September 15, 2022
Last Updated
November 4, 2020
Record last verified: 2020-11