[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614943":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":34,"locations":43,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":92,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CALM-TF plus Usual Care","EXPERIMENTAL","Participants receive Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF), a brief manualized psychotherapeutic intervention consisting of 3-6 individual sessions over 3-6 months (45-60 minutes each). Sessions delivered via secure video conferencing (Microsoft Teams), telephone, or in-person based on participant preference. Participants also continue to receive usual standard of care throughout the intervention period.",[13],"Behavioral: Trauma-Focused Managing Cancer and Living Meaningfully",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care Alone","NO_INTERVENTION","Participants receive usual standard of care only, which includes frequent conversations with their medical team regarding their care and meetings with social workers regarding financial or other practical issues. Participants have access to formal or specialized psychotherapeutic interventions upon referral by their primary physician or member of their circle of care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Trauma-Focused Managing Cancer and Living Meaningfully","CALM-TF is a brief, manualized psychotherapeutic intervention that incorporates trauma-focused elements into the established CALM framework. It includes a present-oriented focus with particular attention to affect regulation, relational support, and attachment security, specifically designed to address traumatic stress symptoms triggered by a diagnosis or recurrence.\n\nThe intervention consists of 3-6 sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions are delivered by trained therapists through multiple modalities including secure web-conferencing software (Microsoft Teams), telephone, or in-person visits based on patient preference.\n\nCALM-TF focuses on four broad and interconnected content domains: (1) symptom management and communication with healthcare providers; (2) changes in self and in relationships with close others; (3) sense of meaning and purpose in life; and (4) hopes and fears about the future and mortal",[9],[26],"CALM-TF",[28,32],{"name":29,"affiliation":30,"role":31},"Stephanie Lheureux, MD, PhD","Princess Margaret Cancer Centre, University Health Network","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":31},"Gary Rodin, MD",[35,39],{"name":33,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","416-946-4504","gary.rodin@uhn.ca",{"name":40,"role":36,"phone":41,"phoneExt":18,"email":42},"Anne Rydall, MSc","416-910-7349","anne.rydall@uhn.ca",[44],{"facility":45,"status":18,"city":46,"state":47,"zip":18,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Princess Margaret Cancer Centre","Toronto","Ontario","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.39864,43.70643,{"lat":54,"lon":53},[57],{"name":40,"role":36,"phone":41,"phoneExt":18,"email":42},{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[61],{"name":62,"class":63},"Ovarian Cancer Canada","UNKNOWN","100614943","phase-3-trauma-focused-managing-cancer-and-living-meaningfully-calm-tf-for-newly-diagnosed-and-recurrent-ovarian-cancer-100614943",false,"NCT07286162","Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer","Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF): A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Patients With Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence\n* Age 18 years or older\n* Able to speak and read English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires\n* Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention\n* Receiving ongoing psychotherapy at the time of recruitment","FEMALE","18 Years",{"count":74,"type":75},300,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence.\n\nThe main questions it aims to answer are:\n\n1. What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months?\n2. What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone?\n3. What are patient perceptions of their care experiences as explored through qualitative interviews?\n\nResearchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress.\n\nParticipants will:\n\n* Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only\n* Complete questionnaires at baseline, 3 months, and 6 months\n* Continue to receive their standard cancer care throughout the study\n* Some participants may be invited to participate in qualitative interviews at 6 months",[81,82],"Ovarian Cancer (OvCa)","Recurrent Ovarian Cancer",[84,85,86,87,88,89,90,91],"randomized controlled trial","ovarian cancer","recurrence","newly diagnosed","CALM","Managing Cancer And Living Meaningfully","Psychotherapy","psychosocial support","NOT_YET_RECRUITING","2026-01-23",{"date":95,"type":96},"2026-01-27","ACTUAL",{"date":98,"type":75},"2026-03-01",{"date":100,"type":75},"2031-12-31",{"name":5,"class":6},1]