Psyco Quality of Life and Procreation BRCA1/2

Breast Cancer Clinical Trial

— QoL  

Official title:

Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857670
• Other study ID #: RS1702/22
• Status: Recruiting
• Start date: May 31, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Regina Elena Cancer Institute
• Contact: Anita Caruso
• Phone: +39 06 52665332
• Email: anita.caruso[@]ifo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Behavioral:
• Genetic predisposition to breast cancer
Guilt feelings about procreating

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome
Italy	Università dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of feeling guilting	ISGR-15s; Il PFQ-2; PHQ-9	24 monts