[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611119":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":52,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":81,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","The intervention arm will participate in the Living Well app modules and telecoaching sessions.",[13],"Device: Living Well Program",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Living Well Program","The intervention is multicomponent, including a mobile application and telecoaching. The mobile application is comprised of 21 modules integrating psychoeducation and cognitive-behavioral therapy principles, designed to be completed in 3 months. Modules require 15-30 minutes to complete and address topics such as breast cancer education, anxiety management, and adaptive coping strategies. Telecoaching services will provide personalized support for cancer patients throughout their treatment. Participants will complete five 20-30 minute telecoaching sessions with qualified mental health professionals over 6 months.\n\nOutcomes will be compared to a retrospective control cohort.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Scott Irwin, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Angelica Angelica","CONTACT","3104238969","Angelica.Alderete@cshs.org",[32],{"facility":5,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Los Angeles","California","90048","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-118.24368,34.05223,{"lat":42,"lon":41},[45,47],{"name":46,"role":28,"phone":29,"phoneExt":20,"email":30},"Angelica Alderete",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Scott A. Irwin, MD, PhD","Principal Investigator",[53,56],{"name":54,"class":55},"Prosoma","UNKNOWN",{"name":5,"class":6},"100611119","living-well-program-impact-on-healthcare-costs-and-clinical-outcomes-in-breast-cancer-care-100611119",false,"NCT07236437","Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care","Inclusion Criteria:\n\n1. Age 18+\n2. First time breast cancer diagnosis\n3. Established with a Cedars-Sinai Surgical or Medical Oncologist for cancer care and is within 30 days of starting or having started adjuvant or neoadjuvant therapy\n4. Prognosis of greater than 1 year\n5. Breast cancer staging of II-IV\n6. Moderate to severe anxiety (GAD-7 \\>= 10)\n7. English language proficiency\n8. Smartphone and ability to use the application as assessed by study staff (IG only)\n9. Signed dated informed consent form (ICF) within 30 days of diagnosis (IG only)\n\nExclusion Criteria:\n\n1. Prior history of different cancer diagnosis or recurrence of the same cancer\n2. Serious mental illness evidenced by patient self-report, chart review and\u002For diagnosis codes\n3. Presence of suicidal ideation as measured by the Ask Suicide-Screening Questions (ASQ) or a history of suicide attempts as evidenced by self-report or chart review\n4. Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and\u002For diagnosis codes","FEMALE","18 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer?\n\nThe study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.",[73,74,75],"Anxiety","Supportive Care in Cancer","Depression",[73,77,78,79,80],"Breast Cancer","Telecoaching","Telehealth","Supportive Care","NOT_YET_RECRUITING","2025-11-14",{"date":84,"type":85},"2025-11-19","ACTUAL",{"date":87,"type":67},"2025-11-15",{"date":89,"type":67},"2027-11-15",{"name":50,"class":6},1]