[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557736":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":41,"overallOfficials":20,"centralContacts":49,"locations":55,"responsibleParty":75,"collaborators":20,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":20,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility: study enrollment rate","≥40% enrollment among consecutive eligible patients","10 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Feasibility: intervention completion rate","≥50% completion of 2\u002F3 intervention sessions in the HARMONY arm",{"measure":18,"description":19,"timeFrame":12},"Acceptability","≥70% of patients in the HARMONY arm reporting Client Satisfaction Questionnaire-8 (CSQ-8) scores at or above the midpoint score of 20 on a scale from 8-32",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2.\n\nStudy Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"HARMONY","EXPERIMENTAL","HARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook.",[34],"Behavioral: HARMONY",{"label":36,"type":37,"description":38,"interventionNames":39},"Enhanced usual care","ACTIVE_COMPARATOR","The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.",[40],"Other: Enhanced usual care",[42,46],{"type":43,"name":30,"description":44,"armGroupLabels":45,"otherNames":20},"BEHAVIORAL","A psychoeducational intervention for patients with HCC",[30],{"type":6,"name":36,"description":47,"armGroupLabels":48,"otherNames":20},"A supportive care resource guide",[36],[50],{"name":51,"role":52,"phone":53,"phoneExt":20,"email":54},"Kelsey Lau-Min","CONTACT","617-724-4000","klau-min@mgh.harvard.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-71.05977,42.35843,{"lat":67,"lon":66},[70,73],{"name":71,"role":52,"phone":72,"phoneExt":20,"email":54},"Kelsey Lau-Min, MD, MSCE","857-367-1486",{"name":71,"role":74,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Kelsey S. Lau-Min, MD","Principal Investigator","100557736","psychoeducational-intervention-for-patients-with-hepatocellular-carcinoma-100557736",false,"NCT06541990","Psychoeducational Intervention for Patients With Hepatocellular Carcinoma","HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* New diagnosis of HCC within the last six months\n* Ability to complete study procedures English\n\nExclusion Criteria:\n\n* Incidentally diagnosed with HCC after liver transplantation\n* Significant uncontrolled hepatic encephalopathy, cognitive impairment, or psychiatric disorder which will interfere with study participation\n* Patients near the end of life for whom hospice is recommended","ALL","18 Years",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).",[95],"Hepatocellular Carcinoma","2026-10-06",{"date":98,"type":99},"2026-10-09","ACTUAL",{"date":101,"type":99},"2024-10-28",{"date":103,"type":89},"2027-06-30",{"name":5,"class":6},1]