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Patient Experiences After Risk-Reducing Mastectomy Among Women Carrying BRCA1/2 Pathogenic Variants Without a Diagnosis of Breast Cancer

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 16, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
This is a descriptive, exploratory cross-sectional, single-center national study. The study asks a sample of women carrying pathogenic variants associated with hereditary breast and ovarian cancer who have undergone risk-reducing mastectomy (MRR) and have signed informed consent to complete an interview developed on the REDCap platform and sent to their personal email address. The aim of the study is to investigate patients' experiences of satisfaction and their correlations with variables included in the survey, based on evidence from the scientific literature. These variables include aspects derived from the literature and clinical practice, such as: motivations for choosing to undergo MRR, type of surgical procedure performed, type of reconstruction, presence of residual sensitivity, possible postoperative complications, and the number of surgical procedures required to achieve the final outcome; stability of the couple relationship, partner support, impact of surgery on sexuality, the key question regarding the decision to undergo MRR (question no. 11), and whether the participant would recommend the same pathway to others. In addition, the survey includes items derived from the Body Image Scale (Hopwood et al., 2001), translated and validated in Italian (Italian version: Cheli et al., 2016), appropriately adapted to assess the same variable in relation to the MRR procedure (questions no. 2, 4, 6, and 8). Finally, the last section of the survey includes administration of the 12-Item Short Form Survey (SF-12), a widely used measure of quality of life. The questionnaires included in the survey will be appropriately indicated.
Trial Details
NCT Number NCT07821593
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions
(from sponsor)
Heredo Familial Tumors, Psycho Oncological Support
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov