Management of Women With BRCA1/2 Mutation

NCT ID: NCT03211611

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-11-01

Brief Summary

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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

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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.

Conditions

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BRCA1 Mutation BRCA2 Mutation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with BRCA ½ mutation

Women with BRCA 1 / 2 mutation with or without cancer Age over 18

Questionnaire given to the two groups

Intervention Type BEHAVIORAL

Questionnaire given to the two groups :

Patients with BRCA ½ mutation GP

GP

GP of the patients with BRCA 1 / 2 mutation

Questionnaire given to the two groups

Intervention Type BEHAVIORAL

Questionnaire given to the two groups :

Patients with BRCA ½ mutation GP

Interventions

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Questionnaire given to the two groups

Questionnaire given to the two groups :

Patients with BRCA ½ mutation GP

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal PUJOL, PR

Role: STUDY_CHAIR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0200

Identifier Type: -

Identifier Source: org_study_id

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