Clinical trial NCT03211611: Management of Women With BRCA1/2 Mutation
Official title: Role of General Practionners in Management of Women With BRCA1/2 Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRCA1 Mutation
BRCA2 Mutation
Keywords: BRCA1/2 Mutation
Breast cancer
General practitionner
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients' group: women with BRCA 1 / 2 mutation followed-up in the department of genetics at Montpellier University Hospital.

GP group: GP of women included in patients' group.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation.
timeFrame: 1 day
Secondary outcomes:
measure: Women' opinion on their GP
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal PUJOL, PR
role: STUDY_CHAIR
References: