[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591689":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":18,"responsibleParty":33,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":18,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":18,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":18},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient Navigation Program","EXPERIMENTAL","The patient navigation program will integrate 1) education to enhance understanding of the treatment regimen, follow-up care, and the importance of adherence, 2) symptom management and adherence strategies, and 3) skills and resources to enhance women's symptom coping and self-management abilities.",[13],"Behavioral: Patient Navigation Program",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"BEHAVIORAL",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Rebecca Shelby, PhD","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Smrithi Divakaran, MPH","CONTACT","919-681-7695","smrithi.divakaran@duke.edu",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Michael W Willis","919-681-8437","michael.w.willis@duke.edu",{"type":34,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[36],{"name":37,"class":38},"Pfizer","INDUSTRY","100591689","patient-navigation-for-her2-metastatic-breast-cancer-patients-treated-with-tucatinib-100591689",false,"NCT06983691","Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib","Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib","Inclusion Criteria:\n\n* female (sex assigned at birth);\n* ≥18 years of age at enrollment;\n* diagnosed with HER2+ metastatic breast cancer (mBC);\n* receiving treatment with tucatinib combined with capecitabine and trastuzumab;\n* able to speak and read English\n\nExclusion Criteria:\n\n* visual or hearing impairment;\n* severe cognitive impairment;\n* severe mental illness interfering with ability to participate","FEMALE","18 Years",{"count":49,"type":50},26,"ESTIMATED","INTERVENTIONAL",[53],"NA","The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into clinical care to better support mBC patients. The main question the study aims to answer is: is the patient navigation program feasible and acceptable for mBC patients?\n\nParticipants will receive patient navigation sessions over about 6 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3 and 6 weeks after enrollment, with the last assessment occurring after completion of the patient navigation program sessions. Participants will also complete a post-program exit interview.",[56],"HER2+ Metastatic Breast Cancer (MBC)",[58],"Patient Navigation","NOT_YET_RECRUITING","2026-08-05",{"date":62,"type":63},"2026-08-07","ACTUAL",{"date":65,"type":50},"2026-08",{"date":67,"type":50},"2027-03",{"name":5,"class":6}]