[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":61,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Roma La Sapienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","The experimental group will consist of 20 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 20 patients with an indication for reconstruction using the immediate prosthesis technique who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment.",[13],"Other: psychological-clinical intervention with three days of expressive writing by Pennebaker",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","The control group will consist of 20 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 20 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"psychological-clinical intervention with three days of expressive writing by Pennebaker","The psychological-clinical intervention involves five interviews with three days of expressive writing by Pennebaker. During the psychological-clinical interviews the following aspects will be explored:\n\n* Emotions and expectations related to the breast reconstruction process.\n* Feelings related to the perception of one's own body image to promote an integration between the image of one's body and the aspects related to one's own identity and femininity.\n* Thoughts and feelings related to one's relational and social life.\n\nExpressive writing is a technique devised by Pennebaker (1986), who states that expressing deeper thoughts and feelings through writing can improve the physical and psychological health of the individual. The writing task consists of writing about a traumatic experience or a significant event for the person, for a controlled period (usually 15-30 minutes) and on consecutive days (from 2 to 3 days).",[9],[25],{"name":26,"affiliation":27,"role":28},"Carlo Lai","Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","0649917599","carlo.lai@uniroma1.it",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Virginia Campedelli","3402793686","virginia.campedelli@uniroma1.it",[39],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Sant'Andrea Hospital, Faculty of Medicine and Psychology \"La Sapienza'' University of Rome","RECRUITING","Rome","00189","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],12.51133,41.89193,{"lat":50,"lon":49},[53,57],{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Fabio Santanelli Di Pompeo","3483312278","fabio.santanelli@uniroma1.it",{"name":58,"role":31,"phone":59,"phoneExt":18,"email":60},"Maurizio Simmaco","0633775405","maurizio.simmaco@uniroma1.it",{"type":28,"investigatorFullName":26,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Full Professor","100486662","metabolomic-evaluation-of-psycho-surgical-synergy-on-body-image-restoration-after-breast-cancer-100486662",false,"NCT05616988","Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer","BrEva","Inclusion Criteria:\n\n* Presence of diagnosis of breast cancer\n* indication to undergo surgical mastectomy treatment\n* Italian nationality\n* level of education not lower than a secondary school diploma, ensuring sufficient writing skills.\n\nExclusion Criteria:\n\n* the occurrence of metastases and\u002For relapse during the study phase,\n* the refusal of patients to undergo reconstruction treatment\n* the presence of existing psychopathological diagnosis","FEMALE","18 Years",{"count":73,"type":74},80,"ESTIMATED","INTERVENTIONAL",[77],"NA","The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients undergoing surgical mastectomy treatment with post-oncological breast reconstruction. In particular, it is hypothesised that patients undergoing psychological, emotional and social well-being in the phase following surgical treatment, together with an improvement in the inflammatory profile and a possible change in the tryptophan\u002Fkynurenine ratio and cortisol.\n\nFor this purpose, the recruited patients will be randomly divided into two groups. The first experimental group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment.\n\nThe psychological-clinical intervention includes five interviews interspersed with three days of expressive writing by Pennebaker (1986).\n\nThe writing task consists of writing about a traumatic experience or an event significant to the person, for a controlled period of time (usually 15 to 30 minutes) and on consecutive days (2 to 3 days).\n\nThe second control group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research.\n\nIn order to verify the effectiveness of the psychological-clinical intervention, the patients will undergo a psychological evaluation (anxiety, depression, alexithymia, distress, resilience, hope for the future, quality of life, body image, psychological and affective experiences related to breast reconstruction) and a survey of physiological variables (inflammatory response, ratio tryptophan\u002Fkynurenine ratio and salivary cortisol) at the various times envisaged in the study: T0 (1 month pre-surgery mastectomy with breast reconstruction), T1(the day after the end of the psychological-clinical intervention), T2 (3 months post psychological-clinical intervention) and T3 (6 months post psychological-clinical intervention).",[80],"Psychological",[82,83,84,85,86],"Mind-Body Intervention","Metabolomics","Breast Reconstruction","Body Image","Breast Cancer","2024-12-09",{"date":89,"type":90},"2024-12-13","ACTUAL",{"date":92,"type":90},"2022-10-26",{"date":94,"type":74},"2026-11",{"name":5,"class":6},1]