Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT03686605
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability and validity of Thai version of ESAS', 'timeFrame': '1 year', 'description': 'Cut-off point, sensitivity, specificity, positive predictive value and negative predictive value of Thai version of ESAS'}], 'secondaryOutcomes': [{'measure': 'Correlation of Thai version of ESAS, HADS and DSM-5', 'timeFrame': '1 year', 'description': 'Pearson correlation, Sperman rank correlation'}, {'measure': 'Internal consistency of Thai version of ESAS and HADS', 'timeFrame': '1 year', 'description': "Cronbach's alpha"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Screening Tool for Depresion in Cancer Pain Patients']}, 'descriptionModule': {'briefSummary': 'Compare Thai versions of the Edmonton Symptom Assessment System (ESAS) and the Hospiral Anxiety and Depression Scale (HADS) with Diagnostic and Statistical Manual (DSM-5), as a screening tool for depression in cancer pain patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer pain patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients who follow up as out patient at pain clinic, Siriraj hospital\n* Age older than 18 years old\n* Fluently read, write and speak in Thai language\n* No cognitive impairment\n\nExclusion Criteria:\n\n* Unstable clinical presentation\n* Severe pain or pain numerical rating scale more than 7\n* Severe associated symptoms such as nausea, vomiting\n* The patient who do not know their diagnosis'}, 'identificationModule': {'nctId': 'NCT03686605', 'briefTitle': 'The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients', 'orgStudyIdInfo': {'id': 'Si 276/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer pain patients', 'interventionNames': ['Other: Thai version of the Edmontom Symptom Assessment System (ESAS)']}], 'interventions': [{'name': 'Thai version of the Edmontom Symptom Assessment System (ESAS)', 'type': 'OTHER', 'otherNames': ['Thai version of the Hospital Anxiety and Depression Scale (HADS)', 'Thai version of 2Q', 'Thai version of the Mini International Neuropsychiatric Interview (M.I.N.I.)', 'Thai version of the Diagnostic and Statistical Manual (DSM-5)'], 'description': 'Screening and diagnostic questionaire for depression', 'armGroupLabels': ['Cancer pain patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine Siriraj Hospital Mahidol University'}], 'overallOfficials': [{'name': 'Suratsawadee Wangnamthip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Suratsawadee Wangnamthip', 'investigatorAffiliation': 'Mahidol University'}}}}