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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-70
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

he study population consists of women carrying pathogenic variants associated with hereditary breast and ovarian cancer syndromes who have undergone risk-reducing mastectomy (MRR). Participants will be identified among patients previously followed at the clinical center participating in the study and who have provided informed consent to participate. Eligible participants will be invited to complete an online survey developed on the REDCap platform, which will be sent to their personal email address. The survey is designed to collect information regarding their experiences following preventive mastectomy, including satisfaction with the surgical decision, body image perception, quality of life, and relational and psychosocial aspects related to the surgical experience. The study therefore focuses on patient-reported outcomes in women who have undergone preventive breast surgery due to hereditary cancer risk.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Patient satisfaction following risk-reducing mastectomy (MRR).

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

Time frame
Up to December 2026

Secondary outcomes

Other outcomes

Sponsors and contacts

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