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临床试验/NCT02554968
NCT02554968已完成不适用

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

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
182
试验地点
1
主要终点
QuickDASH

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No reported shoulder impairment

结局指标

主要结局

QuickDASH

时间窗: One day

Shoulder Pain and Disability Index

时间窗: One day

Neck Dissection Impairment Index

时间窗: One day

Disability of the Arm, Shoulder and Hand

时间窗: One day

University of Washington Quality of Life Scale (shoulder-subscale)

时间窗: One day

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa M. Eden

PT, DPT, OCS

Mayo Clinic

研究点 (1)

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