Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-28 @ 4:00 AM
Study NCT ID:
NCT05189366
Status:
TERMINATED
Last Update Posted:
2025-10-07
First Post:
2021-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D003147', 'term': 'Communication Disorders'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013070', 'term': 'Speech Therapy'}], 'ancestors': [{'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2021-12-28', 'studyFirstSubmitQcDate': '2021-12-28', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective is to compare the level of anxiety in the experimental arm with the control arm at 6 months.', 'timeFrame': '6 months', 'description': 'Anxiety levels will be measured using the Hospital Anxiety and Depression Scale at 6 months in both treatment arms. The quality of life scale consists of 14 items scored from 0 to 3. A score of 0 indicates that the patient has no anxiety disorder, a score of 21 indicates that the patient has a severe anxiety disorder.'}], 'secondaryOutcomes': [{'measure': "The secondary objective is to evaluate the impact of the practice of sophrology on the patient's quality of life", 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by quality of life questionnaires at baseline and after 3 and 6 months of treatment. These are the QLQ-C30 v3 questionnaire and the brain-specific module EORTC-BN20 ;'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sophrology', 'Speech therapy'], 'conditions': ['Glial Tumor']}, 'descriptionModule': {'briefSummary': "Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders.\n\nIn addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate.\n\nAfter having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy.\n\nOur hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven grade III and IV glial tumours requiring speech therapy;\n* Patient willing to start outpatient speech therapy;\n* Patient aged 18 years and over;\n* Informed patient who has signed consent;\n* Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Patient who has already had an initiation to sophrology in the context of his pathology;\n* PS ≥ 4 ;\n* Patients suffering from psychiatric disorders; delusional phases, schizophrenia against the practice of sophrology;\n* Patient unable to follow the protocol (filling in questionnaires, attendance of sophrology and/or speech therapy sessions) for geographical, social or psychological reasons;\n* Patients who do not speak French;\n* Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian.\n* Women who are pregnant, likely to be pregnant or breastfeeding;'}, 'identificationModule': {'nctId': 'NCT05189366', 'acronym': 'SOPHNEURO', 'briefTitle': 'Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy', 'orgStudyIdInfo': {'id': 'ICO-2020-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm : Speech therapy + Sophrology', 'description': "In the experimental arm, patients will receive 6 sessions of sophrology. The sessions are individual and last approximately 50 minutes.\n\nIn addition to the sophrology sessions, patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.", 'interventionNames': ['Behavioral: Sophrology', 'Behavioral: Speech therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm : Speech therapy', 'description': "Patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.", 'interventionNames': ['Behavioral: Speech therapy']}], 'interventions': [{'name': 'Sophrology', 'type': 'BEHAVIORAL', 'description': "Sophrology is a relaxation method that's sometimes referred to as hypnosis, psychotherapy, or a complementary therapy.\n\nSophrology uses techniques such as: hypnosis, visualization, meditation, mindfulness, breathing exercises, gentle movements, body awareness...\n\nSophrology techniques may be useful during medical procedures that cause stress and discomfort.\n\nSophrology techniques may be useful during medical procedures that cause stress and discomfort.\n\nPatients will receive 6 sessions of sophrology", 'armGroupLabels': ['Experimental arm : Speech therapy + Sophrology']}, {'name': 'Speech therapy', 'type': 'BEHAVIORAL', 'description': "Speech therapy is a treatment that can help improve communication skills. patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.", 'armGroupLabels': ['Control arm : Speech therapy', 'Experimental arm : Speech therapy + Sophrology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'CELINE THOMAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}