Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT03888651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2019-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2019-03-22', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of chronic opioid use', 'timeFrame': 'At 90 days after surgery', 'description': 'Rate of chronic opioid use will be measured by the association of chronic opioid use with that of the risk of opioid misuse Screener and Opioid Assessment for Patients tool (SOAPP-14)'}, {'measure': 'Severity of symptom burden', 'timeFrame': 'At 90 days after surgery', 'description': 'Will be measured by MDASI.'}, {'measure': 'Association of chronic opioid use', 'timeFrame': 'At 90 days after surgery', 'description': 'Association of chronic opioid use with that of the CAGE-AID scores'}], 'secondaryOutcomes': [{'measure': 'Risk of opioid use assessed', 'timeFrame': 'Up to 90 days after surgery', 'description': 'Screener and Opioid Assessment for Patients with Pain\\[SOAPP-14\\] Score of greater than or equal 7 is considered as risk factor for opioid misuse.'}, {'measure': 'Frequency of positive risk of opioid use disorder', 'timeFrame': 'Up to 90 days post surgery', 'description': 'Will be assessed by Screener and Opioid Assessment for Patients with Pain\\[SOAPP-14.'}, {'measure': 'Frequency of aberrant opioid use behaviors', 'timeFrame': 'Up to 90 days post surgery', 'description': "Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test."}, {'measure': 'Frequency of post-operative complications', 'timeFrame': 'Up to 90 days post surgery', 'description': "Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test"}, {'measure': 'Risk of opioid use will be assessed by CAGE-AID', 'timeFrame': 'Up to 90 days post surgery', 'description': 'CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse'}, {'measure': 'Frequency of positive risk of opioid use disorder', 'timeFrame': 'Up to 90 days post surgery', 'description': 'Will be assessed by CAGE-adapted to include drugs (AID).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck cancer who are having surgery as part of their treatment plan.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Assess prevalence of chronic opioid use and severity of symptom burden (M. D. Anderson Symptom Inventory-Head and Neck \\[MDASI-HN\\]) in patients undergoing surgery of head/neck cancer.\n\nSECONDARY OBJECTIVES:\n\nI. To investigate the extent of association of chronic opioid use with risk of opioid use disorder (as assessed by Screener and Opioid Assessment for Patients with Pain\\[SOAPP-14\\] and Cut down, Annoyed, Guilty and Eye Opener \\[CAGE\\] scores) and psychosocial factors (as assessed by MDASI).\n\nII. To assess frequency of positive risk of opioid use disorder as assessed by Screener and Opioid Assessment for Patients tool (SOAPP-14) and CAGE-adapted to include drugs (AID).\n\nIII. Assess frequency of aberrant opioid use behaviors. IV. Assess frequency of post-operative complications.\n\nOUTLINE:\n\nPatients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Participants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with head and neck cancer scheduled for combined head and neck surgery - plastic surgery free flap\n* Competent to give informed consent\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Patient not willing to participate\n* Not competent to give informed consent\n* Inability to read and write in English'}, 'identificationModule': {'nctId': 'NCT03888651', 'briefTitle': 'Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers', 'orgStudyIdInfo': {'id': '2018-0740'}, 'secondaryIdInfos': [{'id': 'NCI-2018-03357', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0740', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaires, quality of life assessment)', 'description': 'Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Complete quality of life assessment', 'armGroupLabels': ['Observational (questionnaires, quality of life assessment)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaire', 'armGroupLabels': ['Observational (questionnaires, quality of life assessment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lakshmi Koyyalagunta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}