Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-24 @ 1:48 PM
Study NCT ID:
NCT04404920
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2020-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Assessment of Symptoms in Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2015-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of oral symptoms (20)', 'timeFrame': '1 week', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Prevalence of physical / psychological symptoms', 'timeFrame': '1 week', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral symptoms', 'Cancer', 'Palliative care'], 'conditions': ['Oral Complication', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '10964347', 'type': 'RESULT', 'citation': 'Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.'}, {'pmid': '33416995', 'type': 'DERIVED', 'citation': 'Davies A, Buchanan A, Todd J, Gregory A, Batsari KM. Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale. Support Care Cancer. 2021 Aug;29(8):4357-4364. doi: 10.1007/s00520-020-05903-1. Epub 2021 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Observational study of prevalence of oral symptoms in patients with advanced cancer using a novel questionnaire ("Oral symptom assessment scale")', 'detailedDescription': 'A novel questionnaire (the "Oral symptom assessment scale" / OSAS) has been developed to assess a range of oral symptoms in patients with advanced cancer.\n\nThe OSAS consists of 20 symptoms, which were chosen following a review of the literature / discussion with experts in the field. The OSAS was modelled on the Memorial Symptom Assessment Scale (MSAS), and asks about the presence of the symptoms, the frequency of the symptoms (i.e. "rarely"; "occasionally"; "frequently"; or "almost constantly"), the severity of the symptoms (i.e. "slight"; "moderate"; "severe"; or "very severe"), and how much distress they cause (i.e. "not at all"; "a little bit"; "somewhat"; "quite a bit"; or "very much"). The questions relate to the last week.\n\nPatients will be given the OSAS to complete, and also the short form of the MSAS (which asks about the presence, and related distress, of 32 physical / psychological symptoms, including a small number of oral symptoms). Demographic data, cancer diagnosis, and performance status will also be collected. The study involves a single visit / assessment.\n\nDescriptive statistics will be used to present the data, and hierarchical cluster analysis will be used to identify oral symptom clusters. Kappa tests will be used to compare analogous questions on the OSAS and short form MSAS (as part of the validation of the OSAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '250 subjects that are either inpatients or outpatients at study sites (hospital and hospices in the United Kingdom).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18yr; diagnosis of locally advanced / metastatic cancer; already known to the specialist palliative care team\n\nExclusion Criteria:\n\n* inability to give informed consent; inability to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT04404920', 'acronym': 'OASis', 'briefTitle': 'Oral Assessment of Symptoms in Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'An Observational Study of the Frequency of Oral Symptoms in Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'OASis study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Novel questionnaire about oral symptoms ("Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Brighton & Sussex University Hospitals', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'East Sussex Healthcare NHS Trust', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'CT9 4AD', 'city': 'Margate', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Pilgrims Hospice', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'zip': 'DA11 7HQ', 'city': 'Northfleet', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Ellenor Lions Hospice', 'geoPoint': {'lat': 51.44633, 'lon': 0.32551}}, {'zip': 'TN2 4TA', 'city': 'Pembury', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Hospice in the Weald', 'geoPoint': {'lat': 51.14296, 'lon': 0.32187}}, {'zip': 'ME1 2NU', 'city': 'Rochester', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Wisdom Hospice', 'geoPoint': {'lat': 51.38764, 'lon': 0.50546}}, {'zip': 'GU16 7UJ', 'city': 'Camberley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Frimley Park Hospital', 'geoPoint': {'lat': 51.33705, 'lon': -0.74261}}, {'zip': 'KT10 9RL', 'city': 'Esher', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Princess Alice Hospice', 'geoPoint': {'lat': 51.36969, 'lon': -0.36693}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'PO18 8QB', 'city': 'Chichester', 'state': 'Wesr Sussex', 'country': 'United Kingdom', 'facility': "St. Wilfred's Hospice", 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'RH10 6BH', 'city': 'Crawley', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': "St. Catherine's Hospice", 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}], 'overallOfficials': [{'name': 'Andrew Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, there are no plans to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}