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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Patient satisfaction following risk-reducing mastectomy (MRR). — Up to December 2026
  Primary outcome measure: Patient satisfaction will be assessed through responses to the survey specifically designed for this study, including the key question evaluating whether participants would choose to undergo the same preventive surgery again and whether they would recommend the procedure to other women with hereditary breast cancer risk. This outcome reflects the overall subjective evaluation of the surgical decision and postoperative experience. Secondary outcome measures: Body image perception Body image perception will be assessed using selected items adapted from the Body Image Scale (Hopwood et al., 2001), translated and validated in Italian. The adapted questions evaluate changes in body perception, feelings of femininity, and satisfaction with physical appearance following risk-reducing mastectomy. Health-related quality of life Quality of life will be evaluated using the 12-Item Short Form Health Surv

Trial sites (1)

More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy