[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"casa-intervention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:casa-intervention":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100656582","phase-1-beyond-psychological-distress-implementation-of-a-dyadic-behavioral-intervention-targeting-neuroendocrine-and-mrna-translational-pathways-in-late-stage-breast-cancer-100656582",false,"NCT07828288","Beyond Psychological Distress: Implementation of a Dyadic Behavioral Intervention Targeting Neuroendocrine and mRNA Translational Pathways in Late-Stage Breast Cancer","Beyond ID","Inclusion Criteria:\n\n* Only eligible patients with a confirmed Stage III or IV breast cancer diagnosis who score above 4 on the Distress Thermometer and their identified caregivers will be recruited for this study.\n\nExclusion Criteria:\n\n* Male patients with a confirmed Stage III or IV breast cancer diagnosis.",true,"ALL","21 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Specific Aim 1: Determine the effect of CASA on psychological distress (primary outcome) and on neuroendocrine, inflammatory, and translational control measures (secondary and exploratory outcomes) in LSBC-PR patients and caregivers. We will conduct a two-arm randomized controlled trial of 70 patient caregiver dyads (35 per arm; N=140 individuals) comparing CASA to usual care, with assessments at baseline (T1) and post-intervention (T2, 5 to 10 weeks). This sample provides 80% power (a=0.05, two-tailed) to detect d=0.80 on the primary outcome, consistent with ORBIT Phase 3 signal confirmation. Psychological distress (Distress Thermometer) is the primary outcome and depressive symptoms (PHQ-8) the secondary psychosocial outcome; patients are the primary analytic unit, with caregivers analyzed in parallel. Plasma cortisol is the key secondary biological outcome; inflammatory cytokines (IL-6, TNF-a, IL-1B, IFN-v, IFN-a, IP-10, CRP) are secondary biological outcomes tested with Benjamin Hochberg FDR control; polysome profiling of PBMCs (with Dr. Dharmawardhane, UPR-MSC) is exploratory. Outcomes are tested hierarchically to control family-wise error. Recruitment, intervention delivery, and biospecimen collection will be conducted at the Puerto Rico Biobank (PRBB) under PMSF-PRI IRB oversight, leveraging Alliance partner collaboration (UPR-MSC and PMSF-PRI). Expected Outcome: CASA will produce greater reductions in psychological distress than usual care, with signals in cortisol and inflammatory cytokines that inform a fully powered R01 to confirm stress-biology mechanisms in LSBC-PR dyads.\n\nSpecific Aim 2: Develop and validate a multilevel implementation strategy for CASA informed by implementation science determinants and stakeholder co-design. Using mixed methods, Consolidated Framework for Implementation Research (CFIR) guided semi-structured interviews (n=20) with oncology and clinic-based stakeholders will be supplemented by validated measures of acceptability, feasibility, and appropriateness. Determinants will be mapped to Expert Recommendations for Implementing Change (ERIC) strategies; co-design sessions will produce a context-specific implementation blueprint. Expected Outcome: A stakeholder-validated implementation strategy that identifies key determinants of CASA uptake and provides an actionable roadmap for scalable delivery across Puerto Rican oncology settings.",[27,28],"CASA Intervention","Usual Care",[30],"CANCER, BREAST, ADVANCED CANCER, Psychosocial support","NOT_YET_RECRUITING","2026-09-14",{"date":34,"type":35},"2026-09-18","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2028-07-30",{"name":41,"class":42},"Ponce Medical School Foundation, Inc.","INDUSTRY"]