[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516246":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":12,"locations":25,"responsibleParty":45,"collaborators":12,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":12,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":12,"overallStatus":28,"whyStopped":12,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard treatment","NO_INTERVENTION","Patients in the control arm will be treated as usual after the first-line breast cancer treatment. Specifically, in Valencia, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations.\n\nOn top of that, patients of this group will be offered 3 supportive consultation sessions, over the phone, with generic advice on desired lifestyle choices (physical activity, dietary habits, sleep habits and social mobility) that will be helpful for managing the ongoing treatment",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard treatment + REBECCA","EXPERIMENTAL","Patients will be trained in the use of the complementary monitoring modules of the REBECCA mobile and online monitoring platform, which will be used longitudinally, facilitating the collection of real world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, that provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life.\n\nUnlike those in the \"Standard care\" study-arm, 3 phone-based consultation sessions in the first 12 months of treatment visits will be scheduled based on system-predicted eminent life functionality and emotional state deteriorations (and potential decrease in treatment compliance), targeting the just-in-time patient support, aiming at improving treatment acceptance and efficacy",[18],"Device: REBECCA system (smartwatch + mobile app use)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","REBECCA system (smartwatch + mobile app use)","Patients will be trained in the use of the REBECCA system, which will provide in-depth information about their lifestyle (including physical activity levels, dietary habits, sleep quality and social mobility), as well as of their online behaviour (with outcome indicators of anxiety, PTSD and depression development) and self- or companion-reported measures of emotional state and quality of life. Based on the additional information, exploiting the enhanced monitoring capabilities of the REBECCA system, the supervising clinicians will be given the opportunity to continuously evaluate the progress of the patients, allowing them to schedule up to 3 phone-based consultation sessions in the first 12 months of treatment",[14],[26],{"facility":27,"status":28,"city":29,"state":12,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Hospital Clínico Universitario de Valencia","RECRUITING","Valencia","46010","Spain","ES",{"type":34,"coordinates":35},"Point",[36,37],-0.37966,39.47391,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":12,"email":44},"Tania Fleitas, MD, PhD","CONTACT","+34 616315091","tfleitask@gmail.com",{"type":46,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100516246","evaluation-of-improvements-in-patient-reported-quality-of-life-100516246",false,"NCT06002022","Evaluation of Improvements in Patient-reported Quality of Life","Local Intervention Trial for the Evaluation of Improvements in Patient-reported Quality of Life and Treatment Satisfaction in BCP as a Result of Flexible Treatment Planning Supported by REBECCA-collected RWD","REBECCA-QoL","Inclusion Criteria:\n\n* Before patient registration, written informed consent must be given according to national and local regulations.\n* Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization.\n* Be between 18 and 75 years of age.\n* Have increased life expectancy beyond the initial 3 months post-treatment initiation.\n* Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Patients that are not willing to sign an informed consent form","FEMALE","18 Years","75 Years",{"count":59,"type":60},110,"ESTIMATED","INTERVENTIONAL",[63],"NA","Local intervention trial for the evaluation of improvements in patient-reported Quality of Life and treatment satisfaction, in breast cancer patients (BCP), as a result of flexible treatment planning supported by REBECCA-collected real-world data, in comparison with standard care",[66,67,68,69,70,71],"Breast Cancer","Quality of Life","Physical Activity","Sleep Quality","Stress","Pain","2025-08-05",{"date":74,"type":75},"2025-08-06","ACTUAL",{"date":77,"type":75},"2024-01-01",{"date":79,"type":60},"2025-12-31",{"name":5,"class":6},1]