NF1: Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03298438

Collaborator

(none)

Enrollment

Location

5.6

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatosis 1 Diagnoses Disease Post Traumatic Stress Disorder

Study Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Actual Study Start Date :

Jul 15, 2016

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Outcome Measures

Primary Outcome Measures

Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form [Day 1 after diagnosis of neurofibromatosis]
Questionnaire Impact of Event Scale

Secondary Outcome Measures

Study methods of annoucement and feeling of patients with a questionnaire [Day 1 after diagnosis of neurofibromatosis]
Questionnaires about: methods of announcement (who? when? how?)
Genetical analyze [Day 1 after diagnosis of neurofibromatosis]
Genetical analyze
Psychological or psychiatrical impact [Day 1 after diagnosis of neurofibromatosis]
Psychological or psychiatrical impact
Information about NF1 [Day 1 after diagnosis of neurofibromatosis]
Questions about look for information about disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient aged 18 or more, or parent of a children
Patient with a neurofibromatosis type 1 or parent of a children with a neurofibromatosis 1 in de novo form
Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the University Hospital of Brest, since april 2013
Agree to participate