Management of Women With BRCA1/2 Mutation

NCT03211611 | Completed

• 1 other identifier: RECHMPL17_0200
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

BRCA1 Mutation; BRCA2 Mutation

Keywords

BRCA1/2 Mutation; Breast cancer; General practitionner

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Women' opinion on their GP

  1 day

Study Arms (2)

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

GP

GP of the patients with BRCA 1 / 2 mutation

Behavioral: Questionnaire given to the two groups

Interventions

Questionnaire given to the two groups BEHAVIORAL

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

GP; Patients with BRCA ½ mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged over 18
• Women
• Living in France
• Having a medical insurance

You may not qualify if:

• Men
• Dementia
• Non frenchspeaker
• Mental retardation
• Being the subject of a guardianship or tutelage measure

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pascal PUJOL, PR

  University Hospital, Montpellier

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: April 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: November 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2017-07

Locations

FR (1)