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



Status:Completed
Conditions:Cancer, Cancer, Orthopedic
Therapuetic Areas:Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 90
Updated:7/8/2018
Start Date:September 2015
End Date:September 2017

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

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.

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.

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
We found this trial at
3
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Phone: 480-342-0450
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Phone: 480-342-0450
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Rochester, Minnesota 55905
Phone: 480-342-0450
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Rochester, MN
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