Psyco Quality of Life and Procreation BRCA1/2

NCT05857670 | Unknown

• 1 other identifier: RS1702/22
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Genetic Predisposition

Outcome Measures

Primary Outcomes (1)

• Evaluation of feeling guilting

  * ISGR-15s * Il PFQ-2 * PHQ-9

  24 monts

Interventions

Genetic predisposition to breast cancer BEHAVIORAL

Guilt feelings about procreating

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with BRCA1/2 mutation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (2)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Università dell'Insubria

Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anita Caruso

CONTACT

+39 06 52665332; anita.caruso@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 12, 2023
• Study Start: May 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

IT (2)