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

Mayo Clinic

Status: Completed

Conditions: Shoulder Pain; Head and Neck Cancer

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02554968

15-005266

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

182 participants in 1 patient group

Study participants

Description:

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

Treatment:

Other: Questionnaires