[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-tumor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100637923","effect-of-hypnosis-in-the-management-of-anxiety-and-chemo-induced-symptoms-in-adolescents-and-young-adults-with-sarcoma-or-germ-cell-tumor-and-in-young-women-with-breast-cancer-100637923",false,"NCT07614620","Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer","Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer.","HYPNO-AJA2","Inclusion Criteria:\n\n1. Newly diagnosed patients receiving initial care and follow-up at the Institut Bergonié during treatment:\n\n   1. Adolescents or young adults (AJA) aged 15 to 39 with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),\n   2. Young women aged 15 to 49 with breast cancer.\n2. Treatment with neoadjuvant chemotherapy based on anthracyclines and\u002For alkylating agents.\n3. Treatment administered as:\n\n   1. Inpatient for patients with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),\n   2. Outpatient or day hospital for female patients with breast cancer.\n4. Dated and signed informed consent (if the patient is a minor, consent must also be signed by the legal guardians).\n5. Patient enrolled in a social security program in accordance with current regulations.\n\nExclusion Criteria:\n\n1. Known contraindications to hypnosis (psychotic disorders, mental disorders, confusion, deafness, severe cognitive impairment, etc.)\n2. Patients who have already undergone hypnosis sessions within 6 months prior to enrollment.\n3. Geographic, social, or psychological factors rendering the patient unable to comply with the study's follow-up and procedures.\n4. Patients who are deprived of their liberty or subject to a legal protection measure (guardianship, conservatorship, judicial protection, or family authorization).","ALL","15 Years","49 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","The HYPNO-AJA 2 study is a prospective single-center interventional clinical trial conducted at the Institut Bergonié to evaluate the effectiveness of hypnosis in reducing anxiety and chemotherapy-related symptoms in adolescents, young adults (AYAs), and young women undergoing cancer treatment. The study focuses on patients aged 15-39 with sarcoma or germ cell tumors and women aged 15-49 with breast cancer receiving neoadjuvant chemotherapy.\n\nCancer treatment in AYAs is frequently associated with high levels of psychological distress, particularly anxiety related to chemotherapy sessions, invasive procedures, and repeated hospitalizations. Previous studies suggest that hypnosis may help reduce anxiety, pain, nausea, and emotional distress in oncology patients, but evidence remains limited in AYA populations and specific cancer types such as sarcoma, germ cell tumors, and breast cancer. HYPNO-AJA 2 aims to address this gap by assessing the feasibility, safety, and therapeutic value of hypnosis during chemotherapy.\n\nThe study's primary objective is to determine whether hypnosis can significantly reduce anxiety symptoms during chemotherapy. Secondary objectives include evaluating its effects on nausea and vomiting, pain, medication consumption (anxiolytics and antiemetics), quality of life, body image perception, and patient satisfaction.\n\nThe trial will include 70 participants divided into two cohorts:\n\n* 35 hospitalized patients with sarcoma or germ cell tumors;\n* 35 outpatients with breast cancer treated in a day hospital setting.\n\nEligible participants must be newly diagnosed, treated at Institut Bergonié, and receiving chemotherapy based on anthracyclines and\u002For alkylating agents. Patients with contraindications to hypnosis, severe psychiatric or cognitive disorders, recent hypnosis exposure, or inability to comply with follow-up procedures are excluded.\n\nThe intervention consists of a hypnosis session performed during the second chemotherapy cycle by a specialized oncology nurse trained in Ericksonian hypnosis and pain management. Sessions will last between 30 and 60 minutes and take place in a private and comfortable environment. The hypnosis procedure includes a preparatory discussion, hypnotic induction, progressive return to normal consciousness, and debriefing adapted to the patient's needs.\n\nAnxiety levels will be assessed using a Visual Analog Scale (VAS-Anxiety) before and after chemotherapy cycles 1, 2, and 3. Cycle 2 includes hypnosis, whereas cycles 1 and 3 do not. The primary endpoint is the difference in anxiety levels after cycle 2 compared with cycle 3. Secondary outcomes will evaluate chemotherapy-induced nausea and vomiting using the PRO-CTCAE system, pain intensity, medication use, quality of life through the EORTC QLQ-C30 questionnaire, body image changes using the Body Image Scale, and satisfaction with hypnosis sessions.\n\nThe planned enrollment period is 18 months, with a total study duration of 24 months and individual patient participation lasting approximately six months. Statistical analyses will compare anxiety scores after chemotherapy with and without hypnosis using paired statistical tests. Based on preliminary results from the earlier HYPNO-AJA-1 pilot study, the sample size is expected to provide more than 90% statistical power to detect clinically meaningful reductions in anxiety.\n\nThe investigators expect hypnosis to improve patients' psychological well-being, reduce symptom burden and medication use, enhance quality of life and body image acceptance, and strengthen the therapeutic relationship between patients and caregivers. More broadly, the study may support the integration of hypnosis into supportive oncology care pathways as a low-cost, non-pharmacological intervention adapted to young cancer patients.",[28,29,30,31],"Sarcoma","Germ Cell Tumor of Testis","Ovarian Tumor","Breast Cancer","NOT_YET_RECRUITING","2026-05-22",{"date":35,"type":36},"2026-05-29","ACTUAL",{"date":38,"type":22},"2026-09-15",{"date":40,"type":22},"2028-12",{"name":42,"class":43},"Institut Bergonié","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100524069","prospective-registration-of-the-performance-of-the-iota-adnex-model-in-dutch-gynaecological-practice-100524069","NCT06103916","Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice","PRIORITY","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Presence of a complex ovarian tumor\n3. Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model\n4. Understanding of Dutch language\n\nExclusion Criteria:\n\n1. Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:\n\n   1. Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma\n   2. Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)\n   3. Unilocular tumor with regular walls and maximal diameter \\\u003C 10cm (suggestive of simple cyst or cystadenoma)\n   4. Remaining unilocular tumors with regular walls\n2. Histologically proven malignancy prior to ultrasound",true,"FEMALE","18 Years",{"count":55,"type":22},613,"OBSERVATIONAL","Multicenter prospective cohort study in which patients ≥18 years with an ovarian tumor for which an ultrasound has been performed in accordance with IOTA criteria and the IOTA ADNEX model has been applied are included. Ultrasound data from these patients will be prospectively recorded in a database to determine the diagnostic accuracy of the IOTA ADNEX model in Dutch gynaecological practice.",[30,59],"Ovarian Cancer",[61,62],"ultrasound","ADNEX model","RECRUITING","2023-10-25",{"date":66,"type":36},"2023-10-27",{"date":68,"type":36},"2022-07-15",{"date":70,"type":22},"2028-05",{"name":72,"class":43},"Maxima Medical Center",1]