Management of Women With BRCA1/2 Mutation

BRCA1 Mutation Clinical Trial

Official title:

Role of General Practionners in Management of Women With BRCA1/2 Mutation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211611
• Other study ID #: RECHMPL17_0200
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 1, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Aged over 18

• Women

• Living in France

• Having a medical insurance

Exclusion criteria

• Men

• Dementia

• Non frenchspeaker

• Mental retardation

• Being the subject of a guardianship or tutelage measure

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation

Intervention

Behavioral:
• Questionnaire given to the two groups
Questionnaire given to the two groups : Patients with BRCA ½ mutation GP

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	Women' opinion on their GP	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	1 day