[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614524":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":60,"collaborators":26,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital remote monitoring group (intervention)","EXPERIMENTAL","Participants will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible. Participants will rate symptoms weekly for 90 days using PRO-CTCAE questions to assess symptoms commonly associated with immune-related adverse events (irAEs). Participants will also wear a Fitbit activity tracker (Inspire 3 or similar) for the duration of the study and install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. Data from the wearable devices along with electronic patient-reported outcomes will be used to detect and triage immune-related adverse events.",[13],"Behavioral: Digital remote monitoring intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","ACTIVE_COMPARATOR","This group will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible but will not wear an activity tracker or rate weekly symptoms.",[19],"Other: Usual Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Digital remote monitoring intervention","Responses to the PRO-CTCAE questions range from 0-4. Any grade 2-4 response (reflecting moderate to severe symptoms) will trigger a recommendation that the participant may want to contact their provider about the potentially concerning symptom. Fitbit data points exceeding prespecified thresholds based on physiological norms (for skin temperature and pulse oxygenation) or each participants' historic average (heart rate and activity) will also trigger a recommendation that the participant may want to contact their provider about the potentially concerning data point. Participants will receive weekly data reports that show summaries\u002Fgraphs of recent alerts triggered, symptom ratings, and Fitbit data.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual Care","Participants will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB). They will not complete surveys, wear a Fitbit, or receive recommendations about when they might want to reach out to a provider about potentially concerning symptoms or Fitbit values. Participants will use the standard information they receive from clinic about how to manage their symptoms and when to contact their care team.",[15],[32],{"name":33,"affiliation":5,"role":34},"Carissa A Low","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","412-623-5973","lowca@upmc.edu",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Krina C Durica","duricak@upmc.edu",[44],{"facility":45,"status":26,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-79.99589,40.44062,{"lat":55,"lon":54},[58,59],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Carissa Low","Associate Professor","100614524",false,"NCT07280715","Investigating Real-Time Immunotherapy Symptoms Study","Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy","IRIS","Inclusion Criteria:\n\n* within three months of starting immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for advanced melanoma;\n* age 18 years or older;\n* ability to read and write in English;\n* owns and uses a smartphone capable of running study applications\n\nExclusion Criteria:\n\n* under 18 years old; and\n* unable to read and write in English","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:\n\n* Is the digital remote patient monitoring tool feasible and acceptable to patients?\n* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?\n\nParticipants will:\n\n* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.\n* As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).\n\nIf participant is randomly assigned to the intervention group, they will also:\n\n* Complete weekly symptom ratings via digital remote patient monitoring tool\n* Wear a Fitbit activity tracker for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.",[80,81,82],"Cancer","Melanoma (Skin Cancer)","Immunotherapy",[84,85],"quality of life","adverse events","NOT_YET_RECRUITING","2026-05-05",{"date":89,"type":90},"2026-05-11","ACTUAL",{"date":92,"type":74},"2026-06",{"date":94,"type":74},"2026-12-31",{"name":5,"class":6},1]