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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554968
• Other study ID #: 15-005266
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Shoulder Pain

Intervention

Other:
• Questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of the Arm, Shoulder and Hand		One day
Primary	QuickDASH		One day
Primary	Shoulder Pain and Disability Index		One day
Primary	University of Washington Quality of Life Scale (shoulder-subscale)		One day
Primary	Neck Dissection Impairment Index		One day