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

Completed

• Conditions: Shoulder Pain; Head and Neck Cancer
• Interventions: Other: Questionnaires

• Registration Number: NCT02554968
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study participants	Questionnaires	Study participants will complete study related documents including a demographics questionnaire and the shoulder-related patient reported outcome measures.

Primary Outcome Measures

Name	Time	Method
Disability of the Arm, Shoulder and Hand	One day
QuickDASH	One day
Shoulder Pain and Disability Index	One day
Neck Dissection Impairment Index	One day
University of Washington Quality of Life Scale (shoulder-subscale)	One day

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States