[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578930":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":33,"responsibleParty":47,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":25,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"CHU de Quebec-Universite Laval","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate intervention","EXPERIMENTAL","This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.",[13],"Behavioral: Cognitive-behavioral group therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Waiting list group","ACTIVE_COMPARATOR","This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Cognitive-behavioral group therapy","The intervention consists of a 4-week cognitive-behavioral group therapy. Each session is given online and will last 90-minutes. The intervention has been adapted to the population of women with a cancer and a BRCA1\u002F2 mutation from a behavioral-cognitive therapy for fear of cancer recurrence that already exists and has already been proven effective.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Emma Coughlan","CONTACT","418-525-4444","67435","emma.coughlan@crchudequebec.ulaval.ca",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"CHU de Québec-Université Laval","RECRUITING","Québec","Quebec","Canada","CA",{"type":42,"coordinates":43},"Point",[44,45],-71.21454,46.81228,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Josée Savard","Researcher","100578930","cognitive-behavioral-therapy-for-fear-of-cancer-recurrence-in-women-with-brca12-gene-100578930",false,"NCT06817694","Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1\u002F2 Gene","CBT-FCRBRCA1\u002F2","Inclusion Criteria:\n\n* 1\\) Have completed primary treatment for breast or ovarian cancer (i.e., surgery, chemotherapy, and radiotherapy).\n* 2\\) Be known to carry a BRCA1\u002F2 pathogenic mutation.\n* 3\\) Have a clinical level of fear of cancer recurrence as defined by a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale.\n* 4\\) Be at least 18 years of age.\n* 5\\) Be able to read, understand and express herself in French.\n\nExclusion Criteria:\n\n* 1\\) Have distant metastases (in the case of ovarian cancer, only stages IV and IIIC will be excluded).\n* 2\\) Be known to carry a BRCA1\u002F2 \"VUS\" mutation.\n* 3\\) Have a known cognitive disorder.\n* 4\\) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).\n* 5\\) Have already taken part in the original FCR group psychotherapy at the CHU de Québec.\n* 6\\) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.","FEMALE","18 Years",{"count":61,"type":62},250,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to determine whether an adapted version of a current cognitive-behavioural group therapy (CBT) protocol for cancer survivors to the specific needs of women who are carriers of the BRCA1\u002F2 genetic mutation will reduce their levels of fear of cancer recurrence. The main questions this study aims to answer are:\n\n* Will the women who have received the adapted CBT be satisfied with it?\n* Will there be a significant difference in the women's fear of cancer recurrence and other variables (e.g., depression, anxiety, insomnia, fatigue, quality of life) between the comparison groups?\n* Will the effects of the adapted CBT hold over time?\n* What are the roles of different etiological mediating variables in the relationship between fear of cancer recurrence and the effects of the adapted CBT on the severity of fear of cancer recurrence?\n\nResearchers will compare the effects of the adapted CBT between the immediate condition and the waitlist condition.\n\nParticipants will be:\n\n* Either placed in the immediate condition or the waitlist condition (the participants in the waitlist condition will begin their therapy once the immediate group is done with theirs).\n* Taking part in a group CBT session online once a week for eleven weeks.\n* Completing questionnaires pre-intervention, post-intervention, 3 months post-intervention, and 6 months post-intervention.",[68,69,70],"Breast Cancer Susceptibility Gene (BRCA1) Mutation","BRCA2 Mutation","Fear of Cancer Recurrence",[72,73,74,75,76],"BRCA1 Mutation","BRCA 2 Mutation","Fear of cancer recurrence","Cognitive-Behavioral Therapy","Cancer","2026-03-26",{"date":79,"type":80},"2026-03-31","ACTUAL",{"date":82,"type":62},"2026-02",{"date":84,"type":62},"2028-12",{"name":5,"class":6},1]