[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496500":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":26,"armGroups":35,"interventions":41,"overallOfficials":47,"centralContacts":51,"locations":60,"responsibleParty":77,"collaborators":26,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":44,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Rochester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility - SONATA Intervention","Number of patients approached who consent","20 Weeks",{"measure":14,"description":15,"timeFrame":12},"Acceptability- SONATA Intervention","Average general acceptability score using the Theoretical Framework of Acceptability questionnaire. An eight item (range 1 to 5 for each item) psychometrically validated and theoretically informed tool which assesses the following constructs - affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"Estimate - Social Support","Assessed using the Medical Outcomes Study Social Support Survey. The Medical Outcomes Study Social Support Survey is a 19-item survey (range 1-5 for each item) to assess four domains of emotional\u002Finformational support, instrumental support, positive social interaction, and affection; higher scores indicate greater social support. Subjects will be asked about their perceptions of their own social support.",{"measure":21,"description":22,"timeFrame":12},"Estimate - Trust in Healthcare Professionals","Assessed using the the Human Connection (THC) Scale. The THC scale is A 16-item scale (range 1 to 4 for each item); higher scores indicate greater trust.",{"measure":24,"description":25,"timeFrame":12},"Estimate - Adherence to oral anticancer treatments","Assessed using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence). The DOSE-Nonadherence scale is a three-item scale (range from none of the time to every time for each item) with eighteen additional items that assesses reasons for non-adherence.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":32,"maskingDescription":33,"whoMasked":26},"NONE","None (Open Label)","The objective of this study is to conduct a single arm pilot study to assess the feasibility and acceptability of the SONATA intervention among older patients with advanced cancer. We hypothesize that the SONATA intervention will be feasible \\[≥70% enrolled patient subjects (excluding those who die during the study) will complete at least 3 of the SONATA sessions\\] and acceptable \\[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\\]",[36],{"label":37,"type":38,"description":26,"interventionNames":39},"Arm 1 - SONATA Intervention","EXPERIMENTAL",[40],"Behavioral: SONATA",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"BEHAVIORAL","SONATA","The SONATA intervention is composed of five components, network diagnostics, network engagement, opportunity creation, skill building and goal-setting, and feedback, that will be audio-recorded and held over six scheduled sessions.",[37],[48],{"name":49,"affiliation":5,"role":50},"Kah Poh Loh","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":26,"email":55},"CONTACT","585-276-4353","Kahpoh_Loh@URMC.Rochester.edu",{"name":57,"role":53,"phone":58,"phoneExt":26,"email":59},"Becky Gravenstede","585-727-4728","becky_gravenstede@urmc.rochester.edu",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Rochester","New York","14642","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-77.61556,43.15478,{"lat":72,"lon":71},[75,76],{"name":49,"role":53,"phone":54,"phoneExt":26,"email":55},{"name":49,"role":50,"phone":26,"phoneExt":26,"email":26},{"type":50,"investigatorFullName":49,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor - Department of Medicine, Hematology\u002FOncology (SMD)","100496500","a-single-arm-pilot-trial-of-a-social-network-intervention-100496500",false,"NCT05745038","A Single Arm Pilot Trial of a Social Network Intervention","A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer","Patient\n\nInclusion Criteria:\n\n1. Age ≥60 years\n2. A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist\n3. Able to speak English\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1\\) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team\n\nNetwork Members:\n\nInclusion Criteria:\n\n1. Age ≥18 years\n2. Identified as a network member by patient subjects (up to 10 network members)\n3. Able to speak English\n4. Able to provide informed consent.\n\nExclusion Criteria:\n\nNone","ALL","60 Years",{"count":89,"type":90},330,"ESTIMATED","INTERVENTIONAL",[28],"The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \\& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.",[95],"Cancer",[97],"geriatric oncology","2026-09-08",{"date":100,"type":101},"2026-09-10","ACTUAL",{"date":103,"type":101},"2023-11-29",{"date":105,"type":90},"2028-06-30",{"name":5,"class":6},1]