Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT06844461
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VSQOL-It', 'timeFrame': 'From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group', 'description': 'Self evaluation of quality of life in patient diagnosed with sporadic acoustic neuroma. It is composed of 40 questions, of which 37 are built on a Likert scale from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement, and 3 with 3 possible answers. The questions relate to 8 domains: Hearing Problems, Postural Instability and Imbalance, Pain, Discomfort, and Tinnitus, Facial or Ocular Issues, Impact on Physical, Emotional, and Social Well-being, Difficulties with Thinking and Memory, Satisfaction or Regret, Impact on Work Activity.\n\nThe score of questions 1 to 33 is reversed, so that a higher score indicates a favorable health status or better quality of life. The scores for questions 1 to 33 are linearly transformed onto a scale from 0 to 100, where 0 indicates poor quality of life and 100 indicates ideal quality of life. The overall score of the index is calculated as the average of the scores of the first six domains, excluding SatisfactionRegret domain'}, {'measure': 'DRS-It', 'timeFrame': 'From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group', 'description': 'Decisional regret scale to evaluate any regret about the therapeutic choice both in wait-and-scan cohort and surgical cohort. The score ranges from 0 (no regret) to 100 (complete regret). Patients with more than 25pts are considered to have moderate/high regret'}], 'secondaryOutcomes': [{'measure': 'PANQOL', 'timeFrame': 'From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group', 'description': 'Specific quality of life questionnaire in patient with acoustic neuroma composed of 26 questions built on a Likert scale from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement. The questions relate to 7 domains: Hearing (4 questions), Balance (6 questions), Facial Function (3 questions), Energy (6 questions), Anxiety (4 questions), General Health Status (2 questions), and Pain (1 question).\n\nThe score for each domain is calculated as the average of the responses to the questions assigned to it and is linearly transformed onto a scale from 0 to 100, where 0 indicates poor quality of life and 100 indicates ideal quality of life. The overall score of the scale is calculated as the average of the scores of the individual domains.'}, {'measure': 'DASS-21 Questionnaire', 'timeFrame': 'From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group', 'description': 'Psychometric self-evaluation of depression, anxiety and stress during the study period. 21 items-questionnaire about depression, anxiety and stress during the study period. Each subscale presents a singular score from 0 to 42. Higher scores corresponds to worse emotional outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life Outcomes', 'Acoustic Schwannoma']}, 'descriptionModule': {'briefSummary': 'Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients enrolled at the outpatient clinic of an Otolaryngology and Audiology Unit and Neurosurgery Unit of two third level university hospitals in Northern Italy with acoustic neuroma diagnosis between 01/01/2000 and 31/10/2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach\n\nExclusion Criteria:\n\n* Patient with NF2\n* Patient previuosly treated with RT in the head and neck district\n* Patient with pre-treatment facial palsy ipsi and controlateral\n* Patient non native italian speakers\n* Patient with major mental illness already existing before the acoustic neuroma diagnosis\n* Patient with neurological issues such as chronic migraine or postural instability already existing before the acoustic neuroma diagnosis'}, 'identificationModule': {'nctId': 'NCT06844461', 'acronym': 'QOL-DR-NEUROMA', 'briefTitle': 'Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma', 'orgStudyIdInfo': {'id': 'QOL-DR-NEUROMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wait-and-scan cohort', 'description': 'Clinico-radiological follow-up with annual brain MRI to detect increase of volume and size of the tumor'}, {'label': 'Surgery cohort', 'description': 'Surgical cohort with tumor excision through any possible approach to lateral skull base'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cecilia Botti', 'role': 'CONTACT', 'email': 'cecilia.botti@aosp.bo.it', 'phone': '+39 0512143266'}, {'name': 'Cecilia Botti, ENT specialist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Irccs Aou Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Cecilia Botti, ENT Specialist', 'role': 'CONTACT', 'email': 'cecilia.botti@aosp.bo.it', 'phone': '+39 0512143266'}, {'name': 'Alessandro Rosti, PhD Student', 'role': 'CONTACT', 'email': 'alessandro.rosti3@studio.unibo.it', 'phone': '+39 3462245614'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}