Psyco Quality of Life and Procreation BRCA1/2

Recruiting

• Conditions: Breast Cancer; Genetic Predisposition

• Registration Number: NCT05857670
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. BRCA1/2 mutations are inherited as an autosomal dominant manner and therefore there is a 50% probability of transmitting the mutation to the progeny. For this reason, women who have BRCA 1/2 mutation may be less likely to want children than those who test negative. The decision to have children could worry both for the probability to transfer the genetic mutation or because the parenthood could be compromised by the illness and/or by premature death. In previous studies, the psychological condition of patients with BRCA 1/2 mutations, with or without children, was only partially investigated. For this reason the main goal of the study is to deeply investigate the specific psychological condition, with particular attention to the guilt feelings on the possibility to transfer the genetic mutation to the progeny. In this wai it could be useful to development a therapeutic strategies aimed at the best adaptation of the patients to the new health condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Primary Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women with BRCA1/2 mutation affected or not by breast neoplasm
• Women with BRCA1/2 mutation affected or not by breast neoplasm and with at least a son/daughter
• Women with at list middle school diploma
• Women available to do interviews

Exclusion Criteria

• Women with other oncological pathology
• Women with cognitive deficient and/or inability to comply to the requirements of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of feeling guilting	24 monts	* ISGR-15s; * Il PFQ-2; * PHQ-9

Trial Locations

Locations (2)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy

Università dell'Insubria; 🇮🇹 Varese, Italy