Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-04 @ 12:34 AM
Study NCT ID:
NCT04690166
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2020-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Turkish Translation of the London Speech Evaluation Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013065', 'term': 'Speech Intelligibility'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'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': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2020-12-26', 'studyFirstSubmitQcDate': '2020-12-26', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of the Turkish Translation of London Speech Evaluation Scale', 'timeFrame': 'Baseline', 'description': 'Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.'}, {'measure': 'Validation of the Turkish Translation of London Speech Evaluation Scale', 'timeFrame': '6 weeks', 'description': 'Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perceptual', 'speech', 'articulation', 'neck', 'cancer'], 'conditions': ['Speech Intelligibility', 'Speech Disorders', 'Head and Neck Cancer', 'Speech Dysfunction', 'Speech']}, 'referencesModule': {'references': [{'pmid': '21469245', 'type': 'BACKGROUND', 'citation': 'Dwivedi RC, Rose SS, Chisholm EJ, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Development and validation of first-ever speech-specific perceptual speech evaluation tool for patients with head and neck cancer: the London speech evaluation (LSE) scale. Head Neck. 2012 Jan;34(1):94-103. doi: 10.1002/hed.21683. Epub 2011 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.', 'detailedDescription': 'The speech function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as voice analysis computer programmes, scales, or well structured questionnaires. There are many scales for assessment of perceptual speech but there is no validated for head and neck patients. The study will assess the construct validity and adaptation of the Turkish translation of Speech Specific Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators developed the Turkish translation of this scale (LSE-T), according to the cross-cultural adaptation guidelines. Two translators translated the LSE into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores related with perceptual speech in head and neck cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with oral, oropharyngeal cancer and healthy adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to speak, read, understand and write in Turkish\n* History of oral, orofarengeal cancer\n* Volunteers who accept the informed consent\n\nExclusion Criteria:\n\n* Mental disorders\n* Cognitive limitations\n* Able not to speak, read, understand and write in Turkish\n* Underwent any surgery last six month\n* Permanent tracheostomy, total laryngectomy\n* Pregnancy\n* Out of age 18-70 years old\n* Adults who do not accept the informed consent.'}, 'identificationModule': {'nctId': 'NCT04690166', 'briefTitle': 'Validation of the Turkish Translation of the London Speech Evaluation Scale', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Validation and Cultural Adaptation of the Turkish Translation of the London Speech Evaluation Scale', 'orgStudyIdInfo': {'id': '462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Patients', 'description': 'In outpatients clinic, the first group consists of 60 head and neck cancer patients who were treated by ours. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.', 'interventionNames': ['Other: The speech records related to the reading document']}, {'label': 'Healty Control', 'description': 'In outpatients clinic, the control group consists of 60 patients who have not speech and hear impairments. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.', 'interventionNames': ['Other: The speech records related to the reading document']}], 'interventions': [{'name': 'The speech records related to the reading document', 'type': 'OTHER', 'description': 'The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.', 'armGroupLabels': ['Cancer Patients', 'Healty Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof Dr Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ziya Salturk, Asso Prof,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, M.D.', 'investigatorFullName': 'Yavuz Atar', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}