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Completed

NCT Number: NCT02554968

Reliability and Validity of Patient Reported Outcome Measures in 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Primary outcomes

  1. Disability of the Arm, Shoulder and Hand

    Time frame: One day

  2. QuickDASH

    Time frame: One day

  3. Shoulder Pain and Disability Index

    Time frame: One day

  4. University of Washington Quality of Life Scale (shoulder-subscale)

    Time frame: One day

  5. Neck Dissection Impairment Index

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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