Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reliability and Validity of Five Shoulder-Specific Patient Reported Outcome Measures for Use in Patients With Head and Neck Cancer

Conditions
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Shoulder Pain, Head and Neck Cancer

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral neck dissection procedure for management of head and neck cancer within the past 2 weeks to 18 months 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?) 18-90 years of age Adequate fluency in the English language to complete the study-related forms and questionnaires Exclusion Criteria: • No reported shoulder impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study participants<br>Study participants will complete study related documents including a demographics questionnaire and the shoulder-related patient reported outcome measures. | Other: Questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder and Hand |  | One day | 
| QuickDASH |  | One day | 
| Shoulder Pain and Disability Index |  | One day | 
| University of Washington Quality of Life Scale (shoulder-subscale) |  | One day | 
| Neck Dissection Impairment Index |  | One day |