[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656233":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":13,"locations":19,"responsibleParty":38,"collaborators":13,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":13,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":13,"studyType":54,"phases":13,"briefSummary":55,"conditions":56,"keywords":13,"overallStatus":21,"whyStopped":13,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Patient satisfaction following risk-reducing mastectomy (MRR).","Primary outcome measure:\n\nPatient 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.\n\nThis outcome reflects the overall subjective evaluation of the surgical decision and postoperative experience.\n\nSecondary outcome measures:\n\nBody image perception\n\nBody 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.\n\nHealth-related quality of life\n\nQuality of life will be evaluated using the 12-Item Short Form Health Surv","Up to December 2026",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Hereditary breast and ovarian cancer syndromes are most commonly associated with pathogenic variants in genes such as BRCA1 and BRCA2, which confer a significantly increased lifetime risk of developing breast and ovarian cancer. Women carrying these variants frequently face complex medical and psychological decisions regarding risk management strategies.\n\nAmong the available preventive options, risk-reducing mastectomy (MRR) represents one of the most effective strategies to significantly reduce the risk of breast cancer development. Several studies have demonstrated that prophylactic mastectomy can reduce the risk of breast cancer by more than 90% in mutation carriers. However, the decision to undergo MRR is highly personal and involves multiple dimensions including medical risk perception, psychological factors, family history, body image concerns, and expectations regarding reconstructive outcomes.\n\nIn recent years, increasing attention has been devoted not only to the clinical effectiveness of risk-reducing surgery but also to the psychological and quality-of-life outcomes experienced by women undergoing these procedures. Research has shown that while many patients report high levels of satisfaction after surgery, others may experience difficulties related to body image, sexual functioning, emotional adjustment, and expectations regarding surgical results.\n\nThe literature suggests that satisfaction after risk-reducing mastectomy is influenced by several factors including surgical technique, type of breast reconstruction, postoperative complications, preservation of breast sensitivity, partner support, and alignment between preoperative expectations and postoperative outcomes. Moreover, the psychological experience of women undergoing preventive surgery differs significantly from that of patients treated for an existing cancer diagnosis.\n\nDespite growing international literature on this topic, data derived from the Italian context remain limited, particularly regarding patient-reported experiences and satisfaction following preventive mastectomy among women carrying hereditary cancer variants.\n\nUnderstanding the experiences of women who have undergone MRR is crucial for improving counseling processes, enhancing shared decision-making, and optimizing multidisciplinary care for individuals with hereditary cancer risk.\n\nFor this reason, the present study aims to investigate the experiences, perceptions, and satisfaction of women carrying hereditary cancer variants who have undergone risk-reducing mastectomy.\n\nStudy rationale\n\nWomen carrying hereditary pathogenic variants often face a complex and emotionally challenging decision when considering preventive surgery. Although prophylactic mastectomy substantially reduces cancer risk, the intervention has profound implications for body image, sexuality, identity, and interpersonal relationships.\n\nClinical practice suggests that expectations prior to surgery may differ significantly from postoperative experiences. In particular, issues such as aesthetic outcome, loss or alteration of breast sensitivity, the need for multiple surgical procedures, and psychosocial adjustment can influence long-term satisfaction.\n\nFurthermore, relational aspects such as partner support and stability of the couple relationship may play an important role in shaping the psychological adaptation to preventive surgery.\n\nExploring these aspects through patient-reported outcomes may provide valuable insights for clinicians involved in the management of hereditary cancer risk. Such knowledge may contribute to improving genetic counseling, surgical decision-making, and long-term psychosocial support for women undergoing preventive procedures.\n\nThe present study therefore aims to collect systematic data regarding the experiences of women who have undergone risk-reducing mastectomy, focusing on satisfaction, quality of life, body image perception, and relational aspects.\n\nStudy objectives Primary objective\n\nThe primary objective of the study is to evaluate patient satisfaction following risk-reducing mastectomy in women carrying hereditary breast and ovarian cancer variants.\n\nSecondary objectives\n\nSecondary objectives include:\n\ninvestigating the relationship between surgical outcomes and patient satisfaction\n\nexploring body image perception after preventive mastectomy\n\nevaluating the impact of surgery on quality of life\n\nanalyzing the influence of partner support and couple relationship stability on postoperative adaptation\n\nassessing the perceived impact of surgery on sexuality\n\nidentifying factors associated with higher or lower levels of postoperative satisfaction\n\nexploring whether patients would recommend the procedure to other women facing similar decisions\n\nStudy design\n\nThis study is designed as a descriptive exploratory cross-sectional observational study conducted at a single national center.\n\nThe study will involve women carrying pathogenic hereditary cancer variants who have previously undergone risk-reducing mastectomy and who agree to participate by providing informed consent.\n\nParticipants will be invited to complete an online survey designed to collect information regarding their experiences with preventive surgery.\n\nThe survey will be developed using the REDCap electronic data capture platform, which allows secure management of research data and facilitates participation through remote completion.\n\nEligible participants will receive an invitation via email containing a secure link to access the survey.\n\nThe questionnaire will collect data regarding clinical, surgical, psychological, and relational aspects associated with the experience of preventive mastectomy.\n\nStudy population\n\nThe study population consists of women carrying pathogenic variants associated with hereditary breast and ovarian cancer syndromes who have undergone risk-reducing mastectomy.\n\nParticipants will be recruited among patients previously followed at the clinical center involved in the study.\n\nData collection\n\nData will be collected through a structured online survey consisting of multiple sections designed to explore various aspects of the participants' experiences.\n\nThe survey includes questions addressing:\n\nmotivations for choosing risk-reducing mastectomy\n\ntype of surgical procedure performed\n\ntype of breast reconstruction\n\npostoperative complications\n\nnumber of surgical procedures required to achieve the final result\n\npresence or absence of residual breast sensitivity\n\nperception of aesthetic outcome\n\nsatisfaction with the decision to undergo surgery\n\nThe survey also explores psychosocial aspects such as:\n\nstability of the couple relationship\n\nperceived partner support\n\nimpact of surgery on sexual life\n\npsychological adaptation following surgery\n\nParticipants are also asked a key question regarding whether, in retrospect, they would make the same decision again and whether they would recommend the procedure to other women facing a similar situation.\n\nPsychological assessment tools\n\nThe survey incorporates items derived from validated instruments used to assess body image and quality of life.\n\nSpecifically, selected items from the Body Image Scale, originally developed by Hopwood and colleagues and later translated and validated in Italian, have been adapted to assess body image perception in relation to risk-reducing mastectomy.\n\nThese questions evaluate aspects such as:\n\nsatisfaction with physical appearance\n\nfeelings of femininity\n\ncomfort with one's body\n\nperception of physical changes following surgery\n\nIn addition, the final section of the survey includes the 12-Item Short Form Survey (SF-12), a widely used instrument designed to measure health-related quality of life across both physical and mental health domains.\n\nThe inclusion of validated instruments allows for standardized assessment of psychological outcomes and facilitates comparison with existing research.\n\nData analysis\n\nThe study will primarily employ descriptive statistical analyses to summarize participant characteristics and responses to survey items.\n\nContinuous variables will be described using measures such as means and standard deviations, while categorical variables will be summarized using frequencies and percentages.\n\nExploratory analyses may be conducted to investigate potential associations between variables such as surgical characteristics, relational factors, and levels of satisfaction.\n\nThese analyses aim to identify patterns that may contribute to a better understanding of patient experiences following preventive mastectomy.\n\nEthical considerations\n\nParticipation in the study will be entirely voluntary.\n\nAll participants will be required to provide informed consent prior to completing the survey.\n\nData will be collected anonymously and managed in accordance with applicable data protection regulations.\n\nThe use of the REDCap platform ensures secure storage of research data and controlled access for authorized study personnel.\n\nExpected impact\n\nThe findings of this study may provide valuable insights into the experiences of women undergoing risk-reducing mastectomy in the context of hereditary cancer risk.\n\nBy exploring both clinical and psychosocial aspects of preventive surgery, the study may contribute to improving patient counseling, facilitating shared decision-making, and supporting the development of more patient-centered care pathways.\n\nUnderstanding patient satisfaction and quality-of-life outcomes is essential for guiding clinicians in providing balanced information to individuals considering preventive surgery.\n\nFurthermore, the results may help identify areas where additional psychosocial support may be beneficial for women undergoing this complex decision-making process.","he study population consists of women carrying pathogenic variants associated with hereditary breast and ovarian cancer syndromes who have undergone risk-reducing mastectomy (MRR).\n\nParticipants will be identified among patients previously followed at the clinical center participating in the study and who have provided informed consent to participate.\n\nEligible 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.\n\nThe study therefore focuses on patient-reported outcomes in women who have undergone preventive breast surgery due to hereditary cancer risk.",[20],{"facility":5,"status":21,"city":22,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"RECRUITING","Pavia","27100","Italy","IT",{"type":27,"coordinates":28},"Point",[29,30],9.15917,45.19205,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":13,"email":37},"Francesca Dionigi, Psychology","CONTACT","0039 0382501760","f.dionigi@smatteo.pv.it",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Francesca Dionigi","Principal Investigator","100656233","patient-experiences-after-risk-reducing-mastectomy-among-women-carrying-brca12-pathogenic-variants-without-a-diagnosis-of-breast-cancer-100656233",false,"NCT07821593","Patient Experiences After Risk-Reducing Mastectomy Among Women Carrying BRCA1\u002F2 Pathogenic Variants Without a Diagnosis of Breast Cancer","* Female patients aged 18 years or older.\n* Carriers of pathogenic variants associated with hereditary breast and ovarian cancer syndromes (e.g., BRCA1, BRCA2, or other clinically relevant variants).\n* Having previously undergone risk-reducing mastectomy (MRR).\n* Being followed or previously evaluated at the clinical center participating in the study.\n* Ability to understand the study information and complete the survey.\n* Provision of written informed consent for participation in the study.\n* Inability to understand or complete the questionnaire.\n* Refusal or inability to provide informed consent.\n* Incomplete or missing responses to the survey preventing adequate evaluation of the study outcomes.","FEMALE","25 Years","70 Years",{"count":52,"type":53},100,"ESTIMATED","OBSERVATIONAL","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.\n\nThese 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.\n\nIn 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).\n\nFinally, 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.\n\nThe questionnaires included in the survey will be appropriately indicated.",[57,58],"Heredo Familial Tumors","Psycho Oncological Support","2026-09-09",{"date":61,"type":62},"2026-09-16","ACTUAL",{"date":64,"type":62},"2025-05-01",{"date":66,"type":53},"2026-12",{"name":5,"class":6},1]