Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-03-01 @ 12:21 AM
Study NCT ID:
NCT02530112
Status:
TERMINATED
Last Update Posted:
2025-04-11
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcome Measures for Head and Neck Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study proved very difficult to do on paper surveys. The health system is now doing these via the chart with more success.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of Survey', 'timeFrame': '9 years', 'description': 'Completion of quality of life surveys.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Otorhinolaryngology Subjects Undergoing Free Flap Surgery']}, 'descriptionModule': {'briefSummary': "The objective of this study is to identify outcome measures for cancer control in Head and Neck cancer patient populations at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's quality of life, and help with therapeutic interventions and explanation of expectations prior to surgery.", 'detailedDescription': 'Few studies examine quality of life outcome measures with initial diagnosis, surgical procedures,perioperative measures (such as use of perioperative blood transfusion or pressors), and outcomes for cancer control and free flap survival. This sub-protocol, in conjunction with protocol #816676 (Otorhinolaryngology Research Registry) will serve as a hypothesis generating study for future research on reconstructive free flap surgery outcomes by narrowing down existing questionnaires to tailor it specifically for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery.\n\nExclusion Criteria:\n\n* No children, pregnant women, or prisoners will be consented.'}, 'identificationModule': {'nctId': 'NCT02530112', 'briefTitle': 'Functional Outcome Measures for Head and Neck Patients', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Functional Outcome Measures for Head and Neck Patients', 'orgStudyIdInfo': {'id': 'UPCC 17913'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1', 'description': 'First round of survey respondents.', 'interventionNames': ['Other: Survey']}, {'label': 'Phase 2', 'description': 'Second round of survey respondents.', 'interventionNames': ['Other: Survey']}, {'label': 'Phase 3', 'description': 'Third round of survey respondents.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'armGroupLabels': ['Phase 1', 'Phase 2', 'Phase 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Steven Cannady, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}