[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641614":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":40,"centralContacts":22,"locations":44,"responsibleParty":62,"collaborators":22,"id":64,"slug":22,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":22,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":22,"enrollmentInfo":73,"targetDuration":22,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":22,"overallStatus":82,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"OHSU Knight Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive care (ePRO monitoring and referrals)","EXPERIMENTAL","Patients complete an ePRO assessment, where they rate the frequency and\u002For severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment.",[13,14,15,16],"Other: Electronic Health Record Review","Other: Internet-Based Intervention","Behavioral: Patient Navigation","Other: Survey Administration",[18,23,27,34,38],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"Electronic Health Record Review","Ancillary studies",[9],null,{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Internet-Based Intervention","Receive access to ePRO tool",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Patient Navigation","Receive review of symptoms and referral if needed",[9],[33],"Patient Navigator Program",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":22},"Survey Administration","Complete ePRO assessments",[9],{"type":6,"name":35,"description":20,"armGroupLabels":39,"otherNames":22},[9],[41],{"name":42,"affiliation":5,"role":43},"Deanne Tibbitts","PRINCIPAL_INVESTIGATOR",[45],{"facility":5,"status":22,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Portland","Oregon","97239","United States",{"type":51,"coordinates":52},"Point",[53,54],-122.67621,45.52345,{"lat":54,"lon":53},[57,61],{"name":42,"role":58,"phone":59,"phoneExt":22,"email":60},"CONTACT","503-494-4361","tibbitts@ohsu.edu",{"name":42,"role":43,"phone":22,"phoneExt":22,"email":22},{"type":43,"investigatorFullName":42,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Principal Investigator","100641614",false,"NCT07660666","Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor","EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care","Inclusion Criteria:\n\n* PATIENT: Age 18 years or older\n* PATIENT: Histologically confirmed diagnosis of melanoma\n* PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and\u002For National Comprehensive Cancer Network (NCCN) guidelines\n* PATIENT: Willing and able to provide informed consent\n* CAREGIVER: Age 18 years or older\n* CAREGIVER: Family member or primary caregiver of a study participant\n\nExclusion Criteria:\n\n* PATIENT: Previously received ICI therapy\n* PATIENT: Life expectancy of \\\u003C 6 months at time of enrollment\n* PATIENT: Concurrently receiving a non-ICI systemic therapy\n* PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)\n* PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments\n* PATIENT: Unwilling or unable to complete surveys electronically\n* CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)\n* CAREGIVER: Unwilling or unable to complete surveys electronically",true,"ALL","18 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"NA","This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.",[81],"Melanoma","NOT_YET_RECRUITING","2026-06-16",{"date":85,"type":86},"2026-06-22","ACTUAL",{"date":88,"type":75},"2026-11-01",{"date":90,"type":75},"2029-06-01",{"name":5,"class":6},1]