Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT05856656
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.', 'timeFrame': '5 months', 'description': 'Changes in anxiety before the first and third chemotherapy sessions will be measured using the State Trait Anxiety Inventory (= STAI etat score).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Breast Cancer', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.\n\nThe use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with localized breast cancer\n* Indication for adjuvant or neoadjuvant chemotherapy\n* Patient \\> 18 years of age\n* Patient with signed consent\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Metastatic patient\n* Triple negative patient\n* Patient not eligible for curative surgery\n* Patient who has already received chemotherapy\n* Unaided deaf patient\n* Women who are pregnant, likely to be pregnant or breastfeeding\n* A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation\n* Patient who does not understand French\n* Cognitive disorder or inability to understand,\n* Patient protected by law, under court protection, guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT05856656', 'acronym': 'CENSORIAL', 'briefTitle': 'Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer', 'orgStudyIdInfo': {'id': 'ICO-2022-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music therapy arm', 'description': 'A music therapy will be offered to patients before the first 3 chemotherapy cycles', 'interventionNames': ['Behavioral: Music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care arm', 'description': 'Standard patient care, no intervention'}], 'interventions': [{'name': 'Music therapy', 'type': 'BEHAVIORAL', 'description': 'Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.', 'armGroupLabels': ['Music therapy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Sandra PIQUIN', 'role': 'STUDY_DIRECTOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}