[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607256":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":51,"locations":56,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":34,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":34,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":58,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - self-management coaching, telemonitoring","EXPERIMENTAL","Patients and their FCGs participate in self-management coaching sessions over 60 minutes each prior to CAR-T infusion and at approximately days 21, 42, and 70 post-CAR-T infusion. Beginning 15-20 days post CAR-T infusion, participants wear a FitBit device and use a mobile app QD three times per week for 90 days for tracking by nurses of daily steps, temperature, blood pressure, oxygen level, weight, and distress levels.",[13,14,15],"Other: Educational Intervention","Procedure: Health Telemonitoring","Other: Questionnaire Administration",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm B - Standard of Care Arm ( Enhanced usual care)","ACTIVE_COMPARATOR","Patients and their FCGs receive usual care, including standard print educational materials on study.",[15,21],"Other: Best Practice",[23,29,35,39],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Educational Intervention","Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions",[9],[28],"Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Health Telemonitoring","Wear a FitBit device and use a mobile app for nurse tracking",[9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Questionnaire Administration","Ancillary studies",[9,17],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Best Practice","Given usual care",[17],[44],"best practice, standard of care, standard of care, standard of care, standard therapy",[46,49],{"name":47,"affiliation":5,"role":48},"Virginia Sun, PhD, RN","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":5,"role":48},"Saro Armenian, DO, MPH",[52],{"name":47,"role":53,"phone":54,"phoneExt":34,"email":55},"CONTACT","626-218-3122","vsun@coh.org",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":34},"RECRUITING","Duarte","California","91010","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-117.97729,34.13945,{"lat":68,"lon":67},{"type":71,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[73],{"name":74,"class":75},"United States Department of Defense","FED","100607256","phase-3-digital-health-intervention-for-self-management-and-telemonitoring-in-chimeric-antigen-receptor-car-t-therapy-100607256",false,"NCT07186192","Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy","Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy","Inclusion Criteria:\n\nPatient Inclusion Criteria Informed Consent and Willingness to Participate\n\n1. Documented informed consent of the participant and\u002For legally authorized representative Age and Language Criteria\n2. Age ≥ 18 years old at the time of enrollment\n3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria\n4. Relapsed or refractory hematologic malignancy\n5. Scheduled to receive outpatient standard of care (SOC) CAR-T therapy\n6. Has a FCG committed to living with the patient for the duration of the study\n\nFamily Caregiver Inclusion Criteria Informed Consent and Willingness to Participate\n\n1. Documented informed consent of the participant and\u002For legally authorized representative Age and Language Criteria\n2. Age ≥ 18 years old at the time of enrollment\n3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria\n4. Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care\n\nExclusion Criteria 1. An employee who is under the direct\u002Findirect supervision of the PI\u002F a co-investigator\u002F the study manager 2. A direct study team member\n\n\\-",true,"ALL","18 Years",{"count":87,"type":88},190,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).",[94],"Hematologic Malignancies",[96,97],"CAR-T","Digital health intervention","2026-01-27",{"date":100,"type":101},"2026-01-28","ACTUAL",{"date":103,"type":101},"2026-01-14",{"date":105,"type":88},"2029-03-29",{"name":5,"class":6},1]