[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605976":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":66,"collaborators":18,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":96,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Hospital Costa del Sol","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SerenApp Intervention","EXPERIMENTAL","Participants in this group will receive access to SerenApp for 8 weeks. SerenApp is a co-designed digital mental health application for breast cancer survivors, aimed at reducing stress, anxiety, and depressive symptoms, and enhancing coping strategies and empowerment. Participants will be encouraged to engage with the app modules during the study period and will complete baseline and post-intervention assessments, including validated psychological and usability measures.",[13],"Device: SerenApp Digital Psychological Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Oncological Follow-up","NO_INTERVENTION","Participants in this group will continue to receive standard oncological follow-up care according to routine clinical practice, without access to SerenApp during the study period. They will complete the same baseline and post-intervention assessments as the intervention group, which will allow comparison of psychological, quality of life, and healthcare resource outcomes.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","SerenApp Digital Psychological Intervention","SerenApp is a co-created, personalized digital intervention designed to support the mental health of women in breast cancer follow-up or survivorship. The app includes modules targeting stress coping, anxiety, and depression, delivered via smartphone or computer. Content and functionalities were developed collaboratively with patients and healthcare professionals, ensuring usability, clinical relevance, and adherence to regulatory and ethical standards. The intervention is intended for self-guided use over eight weeks, with monitoring of engagement, completion, and user satisfaction.",[9],[26],{"name":27,"affiliation":28,"role":29},"Irene Zarcos-Pedrinaci, PhD","Hospital Universitario Costa del Sol","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Esperanza Varela-Moreno, PhD","CONTACT","+34951986620","esperanza.varela@ibima.eu",[37,52],{"facility":28,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Marbella","Malaga","29603","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-4.88583,36.51543,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":51,"phoneExt":18,"email":35},"+34951978620",{"facility":53,"status":18,"city":54,"state":18,"zip":55,"country":41,"countryCode":42,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Servicio Canario de la Salud","Santa Cruz de Tenerife","38001",{"type":44,"coordinates":57},[58,59],-16.25462,28.46824,{"lat":59,"lon":58},[62],{"name":63,"role":33,"phone":64,"phoneExt":18,"email":65},"Lilisbeth Perestelo-Pérez, PhD","+34922478267","lilisbeth.peresteloperez@sescs.es",{"type":67,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100605976","digital-tool-for-psychological-support-in-women-with-breast-cancer-100605976",false,"NCT07169539","Digital Tool for Psychological Support in Women With Breast Cancer","SerenApp Project: Protocol for a Pilot Study and Co-Creation of a Digital Tool for Psychological Support in Women Under Follow-Up and Breast Cancer Survivors","SerenApp","Inclusion Criteria:\n\nWomen aged ≥18 years.\n\nHistory of breast cancer with completion of primary treatment (surgery, chemotherapy, and\u002For radiotherapy), currently in follow-up.\n\nAccess to a smartphone or tablet with internet connection.\n\nAbility to understand and provide written informed consent.\n\nSufficient knowledge of Spanish to use the app and complete questionnaires.\n\nExclusion Criteria:\n\nCurrent recurrence or metastatic breast cancer.\n\nSevere cognitive impairment or psychiatric disorder that may interfere with participation (e.g., psychosis, severe dementia).\n\nConcurrent participation in another psychosocial intervention study.\n\nLack of access to digital devices or inability to use mobile applications.\n\n\\-","FEMALE","18 Years",{"count":79,"type":80},90,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study will design, test, and evaluate SerenApp, a digital health tool created to support women after completing treatment for breast cancer. Many women live for many years after breast cancer, but a large number continue to experience emotional difficulties such as anxiety, sadness, stress, or fear of the cancer coming back. These problems can strongly affect quality of life and are often not addressed during routine medical visits.\n\nSerenApp is being developed as a safe, easy-to-use mobile application that provides psychological support and practical resources to help breast cancer survivors manage these challenges. What makes this project different is that the app will be created together with patients and healthcare professionals, to ensure that it responds to real needs and is adapted to the public health system in Spain.\n\nThe main questions of the study are:\n\nCan SerenApp help women feel less anxious, depressed, or stressed and improve their overall quality of life?\n\nWill women and professionals find the app useful, acceptable, and easy to use?\n\nCould this digital tool reduce the need for additional healthcare resources and be cost-effective for the health system?",[86],"Breast Cancer",[88,89,90,91,92,93,94,95],"Breast cancer","Breast cancer survivors","Digital psychological intervention","eHealth","Mobile app","Co-creation","Effectiveness","Cost-effectiveness","NOT_YET_RECRUITING","2025-09-05",{"date":99,"type":100},"2025-09-11","ACTUAL",{"date":102,"type":80},"2025-10-01",{"date":104,"type":80},"2027-12-31",{"name":5,"class":6},2]