[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578114":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":41,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":26,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhance Usual Care","ACTIVE_COMPARATOR","A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.",[13],"Behavioral: Enhanced Usual Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Survivorship Sleep Program","EXPERIMENTAL","4, weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session",[19],"Behavioral: Cognitive Behavioral Therapy - Insomnia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Cognitive Behavioral Therapy - Insomnia","The Survivorship Sleep Program is a virtual program based on cognitive behavioral therapy for insomnia (CBT-I), which teaches evidence based skills to improve sleep-related behaviors, expectations, and environment, to promote relaxation, and to reduce worry. It also involves reducing the time spent in bed in order to improve the quantity and quality of sleep over time. The Survivorship Sleep Program is delivered in 4 weekly sessions by a trained facilitator and includes considerations specific to managing insomnia after cancer diagnosis and treatment. Additionally, 1 booster session is offered at week 6.",[15],null,{"type":22,"name":28,"description":11,"armGroupLabels":29,"otherNames":26},"Enhanced Usual Care",[9],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Daniel L Hall, PhD","CONTACT","617-724-6300","111-133-1766","hall@mgh.harvard.edu",{"name":38,"role":33,"phone":39,"phoneExt":26,"email":40},"Caleb Bolden, BA","6039697927","cbolden2@mgh.harvard.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":34,"phoneExt":35,"email":36},"Daniel Hall, PhD",{"type":59,"investigatorFullName":32,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Assistant Professor of Psychology, Associate Director of Utilization & Evaluation Research, Health Promotion & Resiliency Intervention Research Center, Psychologist, Principal Investigator",[62],{"name":63,"class":6},"American Cancer Society, Inc.","100578114","efficacy-of-synchronous-virtual-cognitive-behavioral-therapy-for-insomnia-across-phases-of-cancer-survivorship-100578114",false,"NCT06807086","Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship","Inclusion Criteria:\n\n1. Cancer survivor, defined as:\n\n   1. (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and\u002For chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or\n   2. (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and\u002For chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or\n   3. (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.\n2. Chronic insomnia (DSM-5 criteria)\n3. Age 18 years or older\n\nExclusion Criteria:\n\n1. Self-reported inability to speak and write in English\n2. Undertreated non-insomnia sleep disorder (e.g., sleep apnea)\n3. Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and\u002For psychiatric hospitalization in the past year\n4. Unwilling or unable to discontinue night shift work","ALL",{"count":72,"type":73},198,"ESTIMATED","INTERVENTIONAL",[76],"NA","This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications.\n\nNotably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1).\n\nThis project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation.\n\nCollectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.",[79],"Insomnia Chronic","2026-03-11",{"date":82,"type":83},"2026-03-13","ACTUAL",{"date":85,"type":83},"2025-01-01",{"date":87,"type":73},"2028-12-28",{"name":5,"class":6},1]