Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-21 @ 5:57 PM
Study NCT ID:
NCT02554968
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2015-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability of the Arm, Shoulder and Hand', 'timeFrame': 'One day'}, {'measure': 'QuickDASH', 'timeFrame': 'One day'}, {'measure': 'Shoulder Pain and Disability Index', 'timeFrame': 'One day'}, {'measure': 'University of Washington Quality of Life Scale (shoulder-subscale)', 'timeFrame': 'One day'}, {'measure': 'Neck Dissection Impairment Index', 'timeFrame': 'One day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Pain', 'Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '34174083', 'type': 'DERIVED', 'citation': 'Eden MM, Kunze KL, Galantino ML, Kolber MJ, Cheng MS. Shoulder-Specific Patient-Reported Outcome Measures for Use in Patients With Head and Neck Cancer: An Assessment of Reliability, Construct Validity, and Overall Appropriateness of Test Score Interpretation Using Rasch Analysis. Phys Ther. 2021 Nov 1;101(11):pzab160. doi: 10.1093/ptj/pzab160.'}]}, 'descriptionModule': {'briefSummary': 'This study will utilize Rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.', 'detailedDescription': 'This study is a cross-sectional, questionnaire-based psychometric study. The purpose of the study is to: (1) use Rasch methodology to assess the reliability, construct validity, and overall appropriateness of test score interpretation of 5 shoulder-related patient reported outcome measures in patients experiencing shoulder dysfunction following neck dissection surgery for head and neck cancer; and (2) based on these findings, provide recommendations of which patient reported outcome measure or combination of measures most accurately reflects shoulder disability in patients who experience shoulder dysfunction following neck dissection surgery. Two-hundred and fifty subjects will be recruited during regularly scheduled clinical visits at Mayo Clinic. Subjects will complete five shoulder-related patient reported outcome measures on only one occasion, therefore subjects will be responsible for study participation only at the time of enrollment and same day completion of study-related documents. Upon the conclusion of data collection, Rasch analysis will be utilized to analyze data related to the research objectives, and descriptive statistics will be utilized to describe the sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients reporting shoulder discomfort, stiffness or weakness following a neck dissection procedure for management of head and neck cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral or bilateral neck dissection procedure for management of head and neck cancer within the past 2 weeks to 18 months\n* Endorse some level of shoulder impairment (Answer "yes" when asked "are you currently experiencing any shoulder weakness or discomfort as a result of your surgery?")\n* 18-90 years of age\n* Adequate fluency in the English language to complete the study-related forms and questionnaires\n\nExclusion Criteria:\n\n• No reported shoulder impairment'}, 'identificationModule': {'nctId': 'NCT02554968', 'briefTitle': 'Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Reliability and Validity of Five Shoulder-Specific Patient Reported Outcome Measures for Use in Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': '15-005266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study participants', 'description': 'Study participants will complete study related documents including a demographics questionnaire and the shoulder-related patient reported outcome measures.', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'armGroupLabels': ['Study participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, DPT, OCS', 'investigatorFullName': 'Melissa M. Eden', 'investigatorAffiliation': 'Mayo Clinic'}}}}