Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 5:58 PM
Ignite Modification Date: 2025-12-24 @ 5:58 PM
NCT ID: NCT02554968
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.
Study: NCT02554968
Study Brief:
Protocol Section: NCT02554968