Clinical trial · Observational
Patient Experiences After Risk-Reducing Mastectomy Among Women Carrying BRCA1/2 Pathogenic Variants Without a Diagnosis of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heredo Familial Tumors | — | UNRESOLVED | — |
| Psycho Oncological Support | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient satisfaction following risk-reducing mastectomy (MRR).
- timeFrame
- Up to December 2026
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
* Female patients aged 18 years or older. * Carriers of pathogenic variants associated with hereditary breast and ovarian cancer syndromes (e.g., BRCA1, BRCA2, or other clinically relevant variants). * Having previously undergone risk-reducing mastectomy (MRR). * Being followed or previously evaluated at the clinical center participating in the study. * Ability to understand the study information and complete the survey. * Provision of written informed consent for participation in the study. * Inability to understand or complete the questionnaire. * Refusal or inability to provide informed consent. * Incomplete or missing responses to the survey preventing adequate evaluation of the study outcomes.
References
Publications (0)
Data not yet available