[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547926":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":56,"centralContacts":31,"locations":60,"responsibleParty":80,"collaborators":31,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":31,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":31,"enrollmentInfo":92,"targetDuration":31,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":31,"overallStatus":62,"whyStopped":31,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Roswell Park Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive Care (ENST)","EXPERIMENTAL","Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and\u002For nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study.",[13,14,15,16,17],"Procedure: Assessment of Distress","Other: Consultation Visit","Other: Nutritional Assessment","Other: Questionnaire Administration","Other: Supportive Care",[19,27,32,40,44,52],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Assessment of Distress","Undergo psychological distress screening",[9],[25,26],"Assessment of Psychological Distress","Evaluation of Patient's Distress",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Consultation Visit","Attend consultations",[9],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Nutritional Assessment","Undergo malnutrition screening",[9],[37,38,39],"Dietary Assessment","dietary counseling","nutritional counseling",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Questionnaire Administration","Ancillary studies",[9],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Supportive Care","Receive access to bladder cancer ENST",[9],[49,50,51],"Supportive Therapy","Symptom Management","Therapy, Supportive",{"type":6,"name":45,"description":53,"armGroupLabels":54,"otherNames":55},"Attend virtual support group meetings",[9],[49,50,51],[57],{"name":58,"affiliation":5,"role":59},"Saby George, MD","PRINCIPAL_INVESTIGATOR",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Buffalo","New York","14263","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-78.87837,42.88645,{"lat":72,"lon":71},[75,79],{"name":58,"role":76,"phone":77,"phoneExt":31,"email":78},"CONTACT","716-845-3159","Saby.George@RoswellPark.org",{"name":58,"role":59,"phone":31,"phoneExt":31,"email":31},{"type":81,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100547926","an-education-and-navigation-support-tool-to-improve-participation-in-care-coordination-among-patients-with-locally-advanced-metastatic-and-unresectable-bladder-cancer-and-their-caregivers-100547926",false,"NCT06414317","An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers","A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer","Inclusion Criteria:\n\n* PATIENTS: Age ≥ 18 years\n* PATIENTS: Metastatic or locally advanced, unresectable bladder cancer\n* PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC)\n* PATIENTS: Subjects can be enrolled any time from initial diagnosis of advanced disease to within 8 weeks after initiation of first-line systemic therapy for advanced bladder cancer\n* PATIENTS: Able to speak, understand, read, and write English\n* CAREGIVERS: Age ≥ 18 years\n* CAREGIVERS: Only caregivers of enrolled patients will be included in the study\n* CAREGIVERS: Should be able to speak, understand, read, and write English\n* CAREGIVERS: Caregivers will be enrolled in the study during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)\n\nExclusion Criteria:\n\n* PATIENTS: Not receiving any form of systemic therapy for bladder cancer due to Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\> 3, co-morbidities, or inadequate organ function\n* PATIENTS: Predominantly small cell histology\n* PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys\n* PATIENTS: Pregnant women\n* CAREGIVERS: Cognitively impaired adults\u002Fadults with impaired decision-making capacity\n* CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers)",true,"ALL","18 Years",{"count":93,"type":94},160,"ESTIMATED","INTERVENTIONAL",[97],"NA","This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Patients with advanced bladder cancer tend to be older, have multiple medical conditions and often have poor access to health care. An ENST may be an effective method to improve participation in treatment decision-making and care planning among patients with locally advanced, metastatic and unresectable bladder cancer and their caregivers.",[100,101,102,103,104],"Locally Advanced Bladder Carcinoma","Metastatic Bladder Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","Unresectable Bladder Carcinoma","2026-01-27",{"date":107,"type":108},"2026-01-29","ACTUAL",{"date":110,"type":108},"2024-01-12",{"date":112,"type":94},"2027-03-31",{"name":5,"class":6},1]