Psyco Quality of Life and Procreation BRCA1/2

NCT ID: NCT05857670

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Genetic Predisposition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Genetic predisposition to breast cancer

Guilt feelings about procreating

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Università dell'Insubria

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anita Caruso

Role: CONTACT

+39 06 52665332

Facility Contacts

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Marco Bellani

Role: primary

Other Identifiers

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RS1702/22

Identifier Type: -

Identifier Source: org_study_id

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