QoL: Psyco Quality of Life and Procreation BRCA1/2

• Sponsor: Regina Elena Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05857670
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 31
• Patients Per Site: 100
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Genetic Predisposition	Behavioral: Genetic predisposition to breast cancer

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision
• Actual Study Start Date: May 31, 2022
• Actual Primary Completion Date: Dec 22, 2022
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. Evaluation of feeling guilting [24 monts]

   ISGR-15s Il PFQ-2 PHQ-9

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Regina Elena" National Cancer Institute	Rome		Italy	00144
2	Università dell'Insubria	Varese		Italy	21100

Sponsors and Collaborators

• Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regina Elena Cancer Institute
• ClinicalTrials.gov Identifier: NCT05857670
• Other Study ID Numbers: RS1702/22
• First Posted: May 12, 2023
• Last Update Posted: May 12, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Genetic Predisposition to Disease

Study Results

No Results Posted as of May 12, 2023