[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633016":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":41,"overallOfficials":46,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":78,"id":82,"slug":27,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":27,"maxAge":27,"enrollmentInfo":90,"targetDuration":27,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":27,"overallStatus":98,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Institut fuer Frauengesundheit","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Time to discontinuation","Time to permanent discontinuation of abemaciclib therapy","From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Persistence rate","Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)","At 6 and 12 months after therapy start",{"measure":19,"description":20,"timeFrame":17},"Satisfaction with Information about Medicines Scale (SIMS-D)","This scale assess the patient´s knowledge about their treatment. The total score ranges from 0 to 17, with higher scores indicating a higher degree of overall satisfaction with information received.",{"measure":22,"description":23,"timeFrame":17},"Medication Adherence Rate Scale (MARS-D)","A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence.",{"measure":25,"description":26,"timeFrame":17},"Bloem's patient typology questionnaire","This 6-item instrument classifies patients into four segments: 1) High Acceptance \u002F High Control (Active\u002FAdjusted): Good mental, low care need. 2) Low Acceptance \u002F High Control (Struggling\u002FActive): High need for support to accept the situation. 3) High Acceptance \u002F Low Control (Resigned\u002FPassive): High need for educational\u002Fproactive support. 4) Low Acceptance \u002F Low Control (Vulnerable\u002FAnxious): Highest care need, requires intense supportive care.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Standardized patient coaching","EXPERIMENTAL","Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)",[40],"Behavioral: Standardized patient coaching",[42],{"type":43,"name":36,"description":44,"armGroupLabels":45,"otherNames":27},"BEHAVIORAL","Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)",[36],[47],{"name":48,"affiliation":49,"role":50},"Peter A. Fasching, Prof. Dr. med.","Department of Obstetrics and Gynaecology, Uniklinikum Erlangen","STUDY_CHAIR",[52],{"name":53,"role":54,"phone":55,"phoneExt":27,"email":56},"Sponsor's study office","CONTACT","+49 15739466438","studien@ifg-erlangen.de",[58],{"facility":59,"status":27,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Department of Obstetrics and Gynaecology","Erlangen","Bavaria","91054","Germany","DE",{"type":66,"coordinates":67},"Point",[68,69],11.00783,49.59099,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":74,"phoneExt":27,"email":75},"Prof. Dr. med. Peter A. Fasching","+4991318533572","fk-studienzentrale@uk-erlangen.de",{"type":77,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[79],{"name":80,"class":81},"Lilly Deutschland GmbH Germany","UNKNOWN","100633016",false,"NCT07521202","IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE","A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.","IMPACT PT","Inclusion Criteria:\n\n* Women age 18 or older at time of ICF signature\n* Patients with HRpos\u002FHER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago\n* Patients treated with abemaciclib according to the SmPC and each center´s medical practice\n* Informed consent given prior to the starting study activities\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Patients with contraindications against abemaciclib according to the current SmPC\n* Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician","FEMALE",{"count":91,"type":92},257,"ESTIMATED","INTERVENTIONAL",[29],"The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.\n\nThe main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.\n\nParticipants will be asked to answer several questionnaires.",[97],"HR+\u002FHER2- Early Breast Cancer","NOT_YET_RECRUITING","2026-04-07",{"date":101,"type":102},"2026-04-09","ACTUAL",{"date":104,"type":92},"2026-06",{"date":106,"type":92},"2030-06",{"name":5,"class":6},1]