[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657748":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":61,"overallOfficials":67,"centralContacts":71,"locations":77,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":45,"enrollmentInfo":105,"targetDuration":45,"studyType":108,"phases":109,"briefSummary":110,"conditions":111,"keywords":117,"overallStatus":126,"whyStopped":45,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University College Cork","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":45},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Patient-Initiated Follow-Up - recruitment rate","Measured by the recruitment rate of patients to the study.","12 months",{"measure":14,"description":15,"timeFrame":12},"Feasibility of Patient-Initiated Follow up - retention rate","Retention rate is measured by the percentage of patients that complete the study.",{"measure":17,"description":18,"timeFrame":12},"Feasibility of Patient-Initiated Follow-Up - survey completion rates","Measured by the number of surveys completed by patients on the study",[20,24,27,30,33,36,39,42],{"measure":21,"description":22,"timeFrame":23},"Symptom Burden","Changes in description of symptoms using symptom-report questionnaire (The questionnaire is a specifically designed 'Symptom Survey'. Score is from 5-50, where smaller scores indicate less symptom severity).","Baseline and 12 months",{"measure":25,"description":26,"timeFrame":23},"Health-Related Quality of Life","Change in cancer-related quality of life scores using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30). The scale goes from 0-126, where higher scores indicate better quality of life.",{"measure":28,"description":29,"timeFrame":23},"Breast Cancer-Specific Quality of Life","Change in breast cancer-specific quality of life scores, measured by European Organisation for Research and Treatment of Cancer Quality of Life in Breast Cancer patients (QLQ-BR42). Scores between 0-168, where lower scores indicate better quality of life",{"measure":31,"description":32,"timeFrame":23},"Self Care Agency","Change in assessment of patient self-care agency and capability, measured using Appraisal of Self Care Agency Scale-Revised (ASAS-R) questionnaire. The scale is scored from 15-75, where higher scores indicate greater self care agency",{"measure":34,"description":35,"timeFrame":12},"Healthcare Utilisation - outpatient visits","Measurement of the number of patient outpatient visits during the study",{"measure":37,"description":38,"timeFrame":12},"Healthcare Utilisation - inpatient admissions","Measurement of number of inpatient admissions during the study",{"measure":40,"description":41,"timeFrame":12},"Healthcare Utilisation - emergency department attendances","Measurement of the number of emergency department attendances during the study.",{"measure":43,"description":44,"timeFrame":12},"Participant Satisfaction and Usability","Questionnaire on acceptability and usability of the intervention and platform. This is a custom designed survey, rated on a scale of 0-85 where higher scores indicate a higher satisfaction.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"NA","SINGLE_GROUP","Participants receive a single nurse-led patient-initiated follow-up intervention supported by ePRO symptom monitoring and symptom-triggered management pathways over 12 months.","SUPPORTIVE_CARE",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","Single-arm complex interventional feasibility study evaluating a nurse-led ePRO-supported Patient-Initiated Follow-Up survivorship model for women with Stage I-III hormone receptor-positive HER2-negative breast cancer receiving adjuvant endocrine therapy. Participants receive continuous access to symptom monitoring, educational resources, automated symptom responses and nurse-led consultations over 12 months. Outcomes include feasibility, symptom burden, quality of life, self-care agency, healthcare utilisation and participant satisfaction.",[55],{"label":56,"type":57,"description":58,"interventionNames":59},"LYSA2PIFU Intervention","EXPERIMENTAL","Participants receive access to a nurse-led patient-initiated follow-up model incorporating symptom management through electronic patient-reported outcomes, automated symptom-support resources, and symptom-triggered nurse consultations.",[60],"Behavioral: Patient-Initiated Follow-Up and ePRO Symptom Management",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":45},"BEHAVIORAL","Patient-Initiated Follow-Up and ePRO Symptom Management","A 12-month survivorship intervention combining electronic symptom monitoring, automated symptom-management resources, educational materials, symptom-specific pathways and nurse-led consultations triggered by participant-reported symptom burden.",[56],[68],{"name":69,"affiliation":5,"role":70},"Josephine Hegarty, PhD","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":45,"email":76},"Katie Johnston, Postdoctoral researcher","CONTACT","00353214903000","kjohnson@ucc.ie",[78],{"facility":79,"status":45,"city":80,"state":45,"zip":45,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":45},"Cork University Hospital","Cork","Ireland","IE",{"type":84,"coordinates":85},"Point",[86,87],-8.47061,51.89797,{"lat":87,"lon":86},{"type":90,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[92,93],{"name":79,"class":6},{"name":94,"class":6},"Irish Cancer Society","100657748","patient-initiated-follow-up-for-women-after-early-breast-cancer-treatment-lysa2pifu-100657748",false,"NCT07840534","Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)","The LYSA (Linking You to Support and Advice) 2 Trial: A Nurse-Led Patient-Initiated Follow-Up (PIFU) Model for Women Who Have Finished Treatment for Breast Cancer","LYSA2PIFU","Inclusion Criteria:\n\n* Female aged ≥18 years\n* Able to read and understand English\n* Access to the internet\n* Stage I-III hormone receptor-positive breast cancer\n* HER2-negative disease\n* Within 12 months of completion of primary curative treatment\n* Receiving or recommended to commence adjuvant endocrine therapy\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Not treated with curative intent\n* Premalignant disease only (DCIS or LCIS)\n* Unable to cooperate adequately with study procedures in the opinion of the investigator or supervising clinician","FEMALE","18 Years",{"count":106,"type":107},30,"ESTIMATED","INTERVENTIONAL",[47],"Women treated for early-stage breast cancer commonly experience ongoing treatment-related symptoms while receiving adjuvant endocrine therapy. The LYSA2PIFU Trial will evaluate the feasibility and acceptability of a nurse-led Patient-Initiated Follow-Up (PIFU) model supported by electronic Patient-Reported Outcomes (ePROs), automated symptom-management resources, educational materials and symptom-triggered nurse consultations.",[112,113,114,115,116],"Breast Cancer","Breast Cancer Survivorship","Cancer Survivorship","Endocrine Therapy","Early Stage Breast Cancer",[113,118,119,120,115,121,122,123,124,125],"Patient-Initiated Follow-Up","Electronic Patient Reported Outcomes","ePRO","Symptom Management","Supportive Care","Quality of Life","Survivorship Care","Digital Health","NOT_YET_RECRUITING","2026-09-22",{"date":129,"type":130},"2026-09-25","ACTUAL",{"date":132,"type":107},"2026-10-01",{"date":134,"type":107},"2028-06-01",{"name":5,"class":6},1]