Management of Women With BRCA1/2 Mutation

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

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.

Study Overview

• Status: Completed
• Conditions: BRCA1 Mutation; BRCA2 Mutation
• Intervention / Treatment: Behavioral: Questionnaire given to the two groups

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Chair: Pascal PUJOL, PR, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Breast cancer; BRCA1/2 Mutation; General practitionner
• Other Study ID Numbers: RECHMPL17_0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No