Management of Women With BRCA1/2 Mutation - Full Text View

Purpose

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.

Condition	Intervention
BRCA1 Mutation BRCA2 Mutation	Behavioral: Questionnaire given to the two groups


Study Type:	Observational
Study Design:	Observational Model: Other Time Perspective: Prospective
Official Title:	Role of General Practionners in Management of Women With BRCA1/2 Mutation

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:

The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. [ Time Frame: 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:

Women' opinion on their GP [ Time Frame: 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


Estimated Enrollment:	600
Actual Study Start Date:	April 1, 2017
Estimated Study Completion Date:	November 1, 2017
Estimated Primary Completion Date:	August 31, 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with BRCA ½ mutation Women with BRCA 1 / 2 mutation with or without cancer Age over 18	Behavioral: Questionnaire given to the two groups Questionnaire given to the two groups : Patients with BRCA ½ mutation GP
GP GP of the patients with BRCA 1 / 2 mutation	Behavioral: Questionnaire given to the two groups Questionnaire given to the two groups : Patients with BRCA ½ mutation GP

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211611

Locations


France
Uhmontpellier
Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators


Study Chair:	Pascal PUJOL, PR	University Hospital, Montpellier

More Information


Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT03211611 History of Changes
Other Study ID Numbers:	RECHMPL17_0200
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	NC


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by University Hospital, Montpellier:


BRCA1/2 Mutation Breast cancer General practitionner

ClinicalTrials.gov processed this record on July 11, 2017