Management of Women With BRCA1/2 Mutation

Completed

• Conditions: BRCA1 Mutation; BRCA2 Mutation
• Interventions: Behavioral: Questionnaire given to the two groups

• Registration Number: NCT03211611
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.

This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.

Detailed Description

PURPOSE: The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.

METHODS:

This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Primary Completion: 2017-08-31
• Study Completion: 2017-11-01
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with BRCA ½ mutation	Questionnaire given to the two groups	Women with BRCA 1 / 2 mutation with or without cancer Age over 18
GP	Questionnaire given to the two groups	GP of the patients with BRCA 1 / 2 mutation

Primary Outcome Measures

Name	Time	Method
The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation.	1 day	Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions

Secondary Outcome Measures

Name	Time	Method
Women' opinion on their GP	1 day	Women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.; The rate of GP wanting a formation in oncogenetic

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France