[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415841":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":35,"locations":43,"responsibleParty":59,"collaborators":12,"id":63,"slug":12,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":12,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","NO_INTERVENTION","The control group will receive the standard of psycho-oncological care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of Care + Structured Hypnotherapy","EXPERIMENTAL","The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.",[18],"Behavioral: Structured Hypnotherapy",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Structured Hypnotherapy","The Intervention includes 10 structured hypnotherapy sessions lasting 45 to 60 minutes. During hypnosis, patients reach a trance-like state comparable to a deep relaxation. The therapist guides the patient verbally and also communicates with the patient.\n\nPatients will be supported to use their own imagination without suggesting any imagery. By repeatedly asking what the patient is perceiving, and by verbally repeating what the patient is saying, the therapist can help the patient to go deeper into trance. In these trance states the patient learns to reduce negative side effects of the chemotherapy and increase the quality of life by activating both physical and mental resources using imagination and focusing on positive memories and feelings.",[14],[26,27],"Structured Psychological Intervention","Hypnosis",[29,32],{"name":30,"affiliation":5,"role":31},"Isabel Ge, Dr.","STUDY_DIRECTOR",{"name":33,"affiliation":5,"role":34},"Christian Schwegler, Dr.","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":12,"email":39},"CONTACT","+49 (0)170 472 47 47","christian@praxisschwegler.ch",{"name":30,"role":37,"phone":41,"phoneExt":12,"email":42},"+41 (0)61 328 58 85","isabellxiang.ge@usb.ch",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital Basel","RECRUITING","Basel","Canton of Basel-City","4031","Switzerland",{"type":52,"coordinates":53},"Point",[54,55],7.57327,47.55839,{"lat":55,"lon":54},[58],{"name":33,"role":37,"phone":12,"phoneExt":12,"email":12},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Christian Schwegler","Scientific Collaborator","100415841",false,"NCT04694885","Quality of Life Improvement During Chemotherapy","Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions","QoLMa","Inclusion Criteria:\n\n* Minimum Age 18 years\n* Female\n* Primary breast cancer\n* Receiving neo-adjuvant or adjuvant chemotherapy\n\nExclusion Criteria:\n\n* Verbal or cognitive deficits that are not compatible with outpatient psychotherapy\n* Not consenting patients and vulnerable persons\n* Psychological disorders that prevent patients from participating in the study (e.g. psychotic disorder)\n* acute suicidality","FEMALE","18 Years",{"count":73,"type":74},62,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy.\n\nThe intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed.\n\nThere are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.",[80,81],"Breast Cancer Female","Chemotherapy Effect",[83,84,85,27,86,87,88,89,90],"Breast cancer","Chemotherapy","Hypnotherapy","Quality of life","Anxiety","Depression","Immunity","Dose-response effect","2025-07-08",{"date":93,"type":94},"2025-07-09","ACTUAL",{"date":96,"type":94},"2021-07-31",{"date":98,"type":74},"2026-12-30",{"name":61,"class":6},1]