Clinical trial NCT02554968: Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Official title: Reliability and Validity of Five Shoulder-Specific Patient Reported Outcome Measures for Use in Patients With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Head and Neck Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reporting shoulder discomfort, stiffness or weakness following a neck dissection procedure for management of head and neck cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability of the Arm, Shoulder and Hand
timeFrame: One day
measure: QuickDASH
timeFrame: One day
measure: Shoulder Pain and Disability Index
timeFrame: One day
measure: University of Washington Quality of Life Scale (shoulder-subscale)
timeFrame: One day
measure: Neck Dissection Impairment Index
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Eden MM, Kunze KL, Galantino ML, Kolber MJ, Cheng MS. Shoulder-Specific Patient-Reported Outcome Measures for Use in Patients With Head and Neck Cancer: An Assessment of Reliability, Construct Validity, and Overall Appropriateness of Test Score Interpretation Using Rasch Analysis. Phys Ther. 2021 Nov 1;101(11):pzab160. doi: 10.1093/ptj/pzab160.