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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02554968
Enrollment
182
Registered
2015-09-18
Start date
2015-09-30
Completion date
2017-09-30
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Shoulder Pain

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.

Interventions

OTHERQuestionnaires

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Disability of the Arm, Shoulder and HandOne day
QuickDASHOne day
Shoulder Pain and Disability IndexOne day
University of Washington Quality of Life Scale (shoulder-subscale)One day
Neck Dissection Impairment IndexOne day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026