Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT07117058
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055088', 'term': 'Early Detection of Cancer'}], 'ancestors': [{'id': 'D042241', 'term': 'Early Diagnosis'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 545}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New rapid screening tool for anxiety-depressive disorders', 'timeFrame': 'At inclusion', 'description': 'This tools is under construction.\n\nItems development of this tool is following 3 steps :\n\n1. Identification of dimensions and generation of items : a combination of a deductive method (literature review) and an inductive method (questioning individuals) are used to identify the various dimensions relevant to the early assessment of anxiety and depressive disorders and generate the corresponding items.\n2. Content validity : the expert judges method to confirm, supplement, or reduce the initial selection of items are used\n3. Response options for content validity : binary response options for questions that are unambiguous are used.\n\nThis tool will contain a maximum of 7 questions for children aged 6 to 10, 8 questions for adolescents aged 11 to 14 (in particular because of an additional question on the use of addictive substances) and 10 questions for the 15-25 age group (with the possibility of finer dimensions)'}, {'measure': 'SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)', 'timeFrame': 'At inclusion', 'description': 'Only for 7-14 years old'}, {'measure': 'HADS (Hospital Anxiety and Depression Scale)', 'timeFrame': 'At inclusion', 'description': 'Only 15-25 years old'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety symptoms', 'childhood cancer', 'screening', 'psychological complication'], 'conditions': ['Generalized Anxiety', 'Introspective & Anxiety-Prone Patient', 'Depression, Anxiety', 'Survivors of Childhood Cancer']}, 'descriptionModule': {'briefSummary': 'In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.', 'detailedDescription': 'The aim of the HARMONY-Tool study is to develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children, adolescents and young adults cured of childhood cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with pediatric cancer before the age of 18, whose intensive treatment had ended at least 3 months prior to inclusion and considered to be in complete remission by the doctor responsible for their treatment,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients diagnosed with pediatric cancer before the age of 18,\n* Patient whose intensive treatment had ended at least 3 months prior to inclusion,\n* Patients considered to be in complete remission by the doctor responsible for their treatment,\n* Patient affiliated to or entitled under a social security scheme,\n* Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.\n\nExclusion Criteria\n\n* Refusal to participate expressed by the patient or minor,\n* Patients whose cancer has relapsed or progressed,\n* Pregnant women, women in labor, breast-feeding mothers,\n* Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,\n* Adults under legal protection (guardianship) or unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT07117058', 'acronym': 'HARMONY-Tool', 'briefTitle': 'Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool', 'orgStudyIdInfo': {'id': '23CH131'}, 'secondaryIdInfos': [{'id': '2024-A02404-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '7-10 years old group', 'description': 'Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children cured of childhood cancer.', 'interventionNames': ['Diagnostic Test: New rapid screening tool for anxiety and depressive disorders', 'Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)']}, {'label': '11-14 years old group', 'description': 'Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in adolescents cured of childhood cancer.', 'interventionNames': ['Diagnostic Test: New rapid screening tool for anxiety and depressive disorders', 'Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)']}, {'label': '15-25 years old group', 'description': 'Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in young adults cured of childhood cancer.', 'interventionNames': ['Diagnostic Test: New rapid screening tool for anxiety and depressive disorders', 'Diagnostic Test: HADS (Hospital Anxiety and Depression Scale)']}], 'interventions': [{'name': 'New rapid screening tool for anxiety and depressive disorders', 'type': 'DIAGNOSTIC_TEST', 'description': 'New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation', 'armGroupLabels': ['11-14 years old group', '15-25 years old group', '7-10 years old group']}, {'name': 'SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.', 'armGroupLabels': ['11-14 years old group', '7-10 years old group']}, {'name': 'HADS (Hospital Anxiety and Depression Scale)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old.', 'armGroupLabels': ['15-25 years old group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'ANNE PAGNIER, MD', 'role': 'CONTACT', 'email': 'anne.pagnier@chu-grenoble.fr', 'phone': '(0)476765893', 'phoneExt': '+33'}, {'name': 'Anne PAGNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69000', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'AMANDINE BERTRAND-REYNAUD, MD', 'role': 'CONTACT', 'email': 'amandine.bertrand@lyon.unicancer.fr', 'phone': '(0)4 69 16 65 50', 'phoneExt': '+33'}, {'name': 'Amandine BERTRAND-REYNAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IHOP', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '76000', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'AUDE MARIE-CARDINE, MD', 'role': 'CONTACT', 'email': 'aude.marie-cardine@chu-rouen.fr', 'phone': '(0)232880714', 'phoneExt': '+33'}, {'name': 'Aude MARIE-CARDINE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42000', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire BERGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Biblis VILLAUME, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '37000', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'JULIEN LEJEUNE, MD', 'role': 'CONTACT', 'email': 'julien.lejeune@chu-tours.fr', 'phone': '(0)2474747', 'phoneExt': '+33'}, {'name': 'Julien LEJEUNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'CLAIRE BERGER, MD', 'role': 'CONTACT', 'email': 'claire.berger@chu-st-etienne.fr', 'phone': '(0)4.77.12.79.37', 'phoneExt': '+33'}, {'name': 'Léonie CASAGRANDA, PhD', 'role': 'CONTACT', 'email': 'leonie.casagranda@chu-st-etienne.fr', 'phone': '+33(0)477127937'}], 'overallOfficials': [{'name': 'CLAIRE BERGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}