[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498909":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":36,"locations":18,"responsibleParty":41,"collaborators":18,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":18,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":70,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":18},{"fullName":5,"class":6},"Vejle Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Shared Decision Making (SDM)","EXPERIMENTAL","Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.",[13],"Other: Shared Decision Making using a Patient Decision Aid.",{"label":15,"type":16,"description":17,"interventionNames":18},"Historical data arm","NO_INTERVENTION","Historical data on the management of patients with an unexpected malignant colorectal polyp from February 2018 to the end of 2022 retrieved through the Danish Colorectal Cancer Group Database, the National Pathology database and the National Patient Register.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Shared Decision Making using a Patient Decision Aid.","The intervention comprises the surgeon actively using the tailored PtDA and SDM with the patient when deciding on the management of an unexpected malignant colorectal polyp.",[9],[25,29,33],{"name":26,"affiliation":27,"role":28},"Helene Würtz, MD","Vejle Hospital, Center for Shared Decision Making and Surgical Department","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Karina D Steffensen, Prof PhD MD","Center For Shared Decision Making, Vejle Hospital","STUDY_CHAIR",{"name":34,"affiliation":35,"role":32},"Hans B Rahr, Prof Dr MD","Surgical Department, Vejle Hospital",[37],{"name":26,"role":38,"phone":39,"phoneExt":18,"email":40},"CONTACT","+4579405623","helene.juul.wurtz3@rsyd.dk",{"type":42,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100498909","phase-2-the-impact-of-a-patient-decision-aid-on-treatment-choices-for-patients-with-an-unexpected-malignant-colorectal-polyp-100498909",false,"NCT05776381","The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp","The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study","Inclusion Criteria:\n\n* Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inoperable due to comorbidity\n* Known residual tumor left in situ after local resection, \\>N0 or \\>M0","ALL","18 Years",{"count":53,"type":54},110,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.\n\nShared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.\n\nThis is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.",[60,61,62,63,64,65],"Shared Decision Making","Colonic Polyp","Decision Aids","Rectal Polyp","Colorectal Polyp","Colorectal Cancer",[67,68,69,60],"non-randomized trial","malignant colorectal polyp","Patient Decision aid","NOT_YET_RECRUITING","2026-04-29",{"date":73,"type":74},"2026-04-30","ACTUAL",{"date":76,"type":54},"2028-02-01",{"date":78,"type":54},"2033-02-01",{"name":5,"class":6}]