[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620172":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":47,"centralContacts":54,"locations":60,"responsibleParty":77,"collaborators":10,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":10,"maxAge":10,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8,14,18,22,26,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"patients that received surgery without any further anticancer treatment",[13],"Other: Questionnaires",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","patients that received surgery followed by adjuvant chemotherapy only",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","patients that received surgery followed by chemotherapy and endocrine therapy",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","patients that received surgery followed by endocrine therapy",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5","patients that received neoadjuvant chemotherapy followed by surgery and no further treatment",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 6","patients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort 7","patients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"Cohort 8","patients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy",[13],[43],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Questionnaires","The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16). EORTC QLQ-C30, EORTC QLQ-BR42 and HADS questionnaires are currently used in clinical practice",[9,15,19,23,27,31,35,39],[48,51],{"name":49,"affiliation":5,"role":50},"Maria Carmela Piccirillo, MD","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":53,"role":50},"Martina Pagliuca, MD","Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples",[55],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},"Maria Lucia Iacovino, MD","CONTACT","+3908117770692","marialucia.iacovino@istitutotumori.na.it",[61],{"facility":62,"status":63,"city":64,"state":10,"zip":10,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"National Cancer Institute of Napoli","RECRUITING","Naples","Italy","IT",{"type":68,"coordinates":69},"Point",[70,71],14.26811,40.85216,{"lat":71,"lon":70},[74],{"name":49,"role":57,"phone":75,"phoneExt":10,"email":76},"+39 081-1777 0280","m.piccirillo@istitutotumori.na.it",{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100620172","financial-toxicity-in-patients-with-early-stage-breast-cancer-100620172",false,"NCT07354165","Financial Toxicity in Patients With Early-stage Breast Cancer","Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer","VOICE - GIM36","Inclusion Criteria:\n\n* Signed informed consent form\n* Age \\> 18 years at the time of study entry\n* Histologically confirmed stage I-III invasive breast carcinoma before starting any systemic treatment.\n\nExclusion Criteria:\n\n* Stage IV invasive breast carcinoma\n* Major cognitive dysfunction or psychiatric disorders\n* Any previous systemic treatment for the current breast cancer","ALL",{"count":89,"type":90},864,"ESTIMATED","OBSERVATIONAL","Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.",[94],"Breast Cancer",[96,97,98,99],"early breast cancer","financial toxicity","quality of life","PROFFIT questionnaire","2026-01-14",{"date":102,"type":103},"2026-01-21","ACTUAL",{"date":105,"type":103},"2025-09-30",{"date":107,"type":90},"2034-09",{"name":5,"class":6},1]