[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500199":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":92,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":9,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":18,"enrollmentInfo":108,"targetDuration":18,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":18,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ENDURE","EXPERIMENTAL","ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT.",[13],"Behavioral: ENDURE",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment As Usual","NO_INTERVENTION","Treatment as usual at each site consists of standard of care clinical practices",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","ENDURE provides patient education through the ENDURE Patient Resource Guide and social support by linking patients to community resources (patient-level), standardizes discussions about expectations for PORT and clinical documentation to enhance communication and care coordination within and across interprofessional cancer teams (team-level), and implements referral tracking across fragmented health systems (organization-level). To facilitate care coordination, ENDURE modifies existing standard of care patient navigation (an evidence-based intervention that addresses barriers to timely cancer care) by adding PORT-focused navigation at three key care transitions: into the cancer care system; from inpatient to outpatient after surgery; and from the surgical team to the radiation oncology team.",[9],[25],{"name":26,"affiliation":5,"role":27},"Evan M Graboyes, MD, MPH","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","843-792-0719","graboyes@musc.edu",[34,53,66,79],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Washington University in St. Louis","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-90.19789,38.62727,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":18,"email":52},"Ryan Jackson, MD","314 362 8641","jackson.ryan@wustl.edu",{"facility":54,"status":36,"city":55,"state":56,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Duke University Medical Center","Durham","North Carolina","27710",{"type":43,"coordinates":59},[60,61],-78.89862,35.99403,{"lat":61,"lon":60},[64],{"name":65,"role":30,"phone":18,"phoneExt":18,"email":18},"Russel R Kahmke, MD, MMCi",{"facility":5,"status":36,"city":67,"state":68,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Charleston","South Carolina","29425",{"type":43,"coordinates":71},[72,73],-79.93275,32.77632,{"lat":73,"lon":72},[76],{"name":77,"role":30,"phone":78,"phoneExt":18,"email":32},"Evan Graboyes, M.D., MPH, FACS","(843) 792-0719",{"facility":80,"status":36,"city":81,"state":82,"zip":83,"country":40,"countryCode":41,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Baylor College of Medicine","Houston","Texas","77030",{"type":43,"coordinates":85},[86,87],-95.36327,29.76328,{"lat":87,"lon":86},[90],{"name":91,"role":30,"phone":18,"phoneExt":18,"email":18},"Vlad C Sandulache, MD, PhD",{"type":27,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Evan Graboyes","Associate Professor-Faculty",[96],{"name":97,"class":98},"National Cancer Institute (NCI)","NIH","100500199","multi-site-trial-of-navigation-vs-treatment-as-usual-to-improve-initiation-of-timely-adjuvant-therapy-100500199",false,"NCT05793151","Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy","A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer","Inclusion Criteria:\n\n1. Age \\>\u002F= 18 years\n2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity\n3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \\>N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.\n4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.\n5. Plan for curative intent surgery at one of the participating centers\n6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).\n\nExclusion Criteria:\n\n1. Inability to speak or read English or Spanish.\n2. Severe mental illness that would prevent trial participation.\n3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \\\u003C 3 cm\n4. Synchronous untreated malignancy expected to impact life expectancy","ALL","18 Years",{"count":109,"type":110},532,"ESTIMATED","INTERVENTIONAL",[113],"NA","The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:\n\n1. Does ENDURE improve initiation of timely PORT relative to treatment as usual?\n2. What are the mechanisms through which ENDURE improves timeliness to treatment?\n3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?",[116,117,118,119,120],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Oropharynx Cancer","Oral Cavity Cancer","Larynx Cancer","2025-12-04",{"date":123,"type":124},"2025-12-11","ACTUAL",{"date":126,"type":124},"2023-10-30",{"date":128,"type":110},"2028-03-30",{"name":5,"class":6},4]