[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07646847":3,"trial-entities:NCT07646847":156,"trial-summary:NCT07646847":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":15,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":60,"locations":63,"central_contacts":142,"overall_officials":149,"references":152,"see_also_links":153},"NCT07646847","25-338","A Study of a Side Effects and Resource Navigation Program for People With Cancer","I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation","RECRUITING","2029-06-09","2026-07","2026-07-31","2026-09-14","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.",[18,19,20,21],"Kidney Cancer","Bladder Cancer","Breast Cancer","Lung Cancer",[18,19,20,21,13,5],"INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},200,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"Immunotherapy CARE Program","For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects\u002Fsymptom reporting navigation",[35],"I CARE Group",[37],"I CARE",[39],{"measure":40,"description":41,"timeFrame":42},"Immune Checkpoint Inhibitors\u002FICI continuation","Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months","6 months",[],"ALL","18 Years",false,{"inclusion":48,"exclusion":58,"raw_text":59},[49,50,51,52,53,54,55,56,57],"Documentation of Disease","Prior Treatment","Age ≥ 18 (per EMR)","Not Pregnant and Not Nursing (per self-report)","At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)","Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)","Can speak English or Spanish (per self-report)","Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)","Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For data collection (per EMR, patient's care team, or study team)",[],"Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)\n* Prior Treatment\n\n  o Within three weeks (+\u002F- 3 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)\n* Age ≥ 18 (per EMR)\n* Not Pregnant and Not Nursing (per self-report)\n* At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)\n* Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)\n* Can speak English or Spanish (per self-report)\n* Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)\n* Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For data collection (per EMR, patient's care team, or study team)",[61,62],"ADULT","OLDER_ADULT",[64,78,87,96,106,115,127,133],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":75},"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[71],{"name":72,"role":73,"phone":74},"Francesca Gany, MD, MS","CONTACT","646-888-8054",{"lat":76,"lon":77},40.70621,-74.54932,{"facility":79,"status":8,"city":80,"state":67,"zip":81,"country":69,"contacts":82,"geoPoint":84},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",[83],{"name":72,"role":73,"phone":74},{"lat":85,"lon":86},40.39428,-74.11709,{"facility":88,"status":8,"city":89,"state":67,"zip":90,"country":69,"contacts":91,"geoPoint":93},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",[92],{"name":72,"role":73,"phone":74},{"lat":94,"lon":95},41.04676,-74.02292,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":69,"contacts":101,"geoPoint":103},"Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)","Commack","New York","11725",[102],{"name":72,"role":73,"phone":74},{"lat":104,"lon":105},40.84288,-73.29289,{"facility":107,"status":8,"city":108,"state":99,"zip":109,"country":69,"contacts":110,"geoPoint":112},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",[111],{"name":72,"role":73,"phone":74},{"lat":113,"lon":114},40.96899,-73.71263,{"facility":116,"status":117,"city":99,"state":99,"zip":118,"country":69,"contacts":119,"geoPoint":124},"City College of New York (Data Collection AND Specimen Analysis)","NOT_YET_RECRUITING","10031",[120],{"name":121,"role":73,"phone":122,"email":123},"Bao Vuong, PhD","212-650-8563","bvuong@ccny.cuny.edu",{"lat":125,"lon":126},40.71427,-74.00597,{"facility":128,"status":8,"city":99,"state":99,"zip":129,"country":69,"contacts":130,"geoPoint":132},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[131],{"name":72,"role":73,"phone":74},{"lat":125,"lon":126},{"facility":134,"status":8,"city":135,"state":99,"zip":136,"country":69,"contacts":137,"geoPoint":139},"Memorial Sloan Kettering Nassau (All protocol activities)","Rockville Centre","11553",[138],{"name":72,"role":73,"phone":74},{"lat":140,"lon":141},40.65871,-73.64124,[143,145],{"name":72,"role":73,"phone":74,"email":144},"ganyf@mskcc.org",{"name":146,"role":73,"phone":147,"email":148},"Neil Shah, MBBS","646-888-4239","ShahN6@mskcc.org",[150],{"name":72,"affiliation":13,"role":151},"PRINCIPAL_INVESTIGATOR",[],[154],{"label":13,"url":155},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":157,"biomarkers":163},[158,159,160,161,162],"Bladder Carcinoma","Breast Carcinoma","Kidney Carcinoma","Lung Carcinoma","Solid Neoplasm",[164,165],"Programmed Cell Death 1 Ligand 1","Programmed Cell Death Protein 1",{"nct_id":4,"found":167,"summary":168,"prompt_version":177},true,{"design":169,"status":170,"heading":6,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This is an interventional study with an unclear status, planning to enroll 200 participants.","completed","This study is looking at an Immunotherapy CARE Program to see if it helps people with kidney, bladder, breast, or lung cancer manage their immunotherapy treatment better. The program involves staff helping with essential needs and reporting side effects. You might be able to join if you are 18 or older, have one of these cancers, and are starting treatment with PD-1 or PD(L)-1 immune checkpoint inhibitors. The study will measure if participants continue their immunotherapy treatment for at least 6 months and will also look at how the program affects your quality of life through questionnaires. The study is currently unclear on its recruitment status and plans to enroll 200 people.","The study measures immunotherapy continuation at 6 months, suggesting follow-up for at least that long.",112,"If assigned to the I CARE arm, CCNY staff will assist you monthly with essential needs and side effects\u002Fsymptom reporting. You will also complete questionnaires to measure your quality of life.","Not stated in the trial record.",[32],"v2"]