[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637935":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":30,"collaborators":11,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":11,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":11,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":11},{"fullName":5,"class":6},"Federico II University","OTHER",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Physician and Patient Trained","EXPERIMENTAL",null,[13],"Behavioral: Shared Decision Making (SDM) Support Program",{"label":15,"type":10,"description":11,"interventionNames":16},"Physician Only Trained",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Patient Only Educated",[13],{"label":21,"type":22,"description":23,"interventionNames":11},"Usual Care","NO_INTERVENTION","Patients and oncologists follow standard care processes. No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient. Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making.",[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"BEHAVIORAL","Shared Decision Making (SDM) Support Program","Comprehensive Shared Decision Making (SDM) program. No drug treatment will be administered in this study. The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice. Depending on the assigned study arm, participants may receive one, both, or neither of these components.",[18,15,9],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Grazia Arpino","Principal Investigator","100637935","shared-decision-making-for-patients-with-her2-negative-metastatic-breast-cancer-sdm-01-100637935",false,"NCT07578415","Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)","Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)","SDM-01","Inclusion Criteria:\n\nConfirmed diagnosis of metastatic breast cancer (MBC).\n\nHER2-negative status (as per ASCO\u002FCAP guidelines).\n\nPatients scheduled to receive or currently receiving their first-line therapy for metastatic disease.\n\nAge ≥ 18 years.\n\nWillingness to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\nDiagnosis of early-stage breast cancer (non-metastatic).\n\nHER2-positive metastatic breast cancer.\n\nAge \\\u003C 18 years.\n\nRefusal to sign the study-specific informed consent form.","FEMALE","18 Years",{"count":45,"type":46},120,"ESTIMATED","INTERVENTIONAL",[49],"NA","Background and Purpose:\n\nDeciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.\n\nStudy Design and Procedures:\n\nThis is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:\n\nThe SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.\n\nThe Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.\n\nWhat to Expect:\n\nPatients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.\n\nGoal:\n\nThe researchers hypothesize that educational training for patients and\u002For physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.",[52,53,54],"Breast Cancer","HER2 Negative Breast Cancer","Metastatic Breast Cancer","NOT_YET_RECRUITING","2026-05-05",{"date":58,"type":59},"2026-05-11","ACTUAL",{"date":61,"type":46},"2026-06",{"date":63,"type":46},"2029-01",{"name":5,"class":6}]