Clinical trial · Observational
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Reliability and Validity of Five Shoulder-Specific Patient Reported Outcome Measures for Use in Patients With Head and Neck Cancer
NCT02554968CI-TRIAL-00033649completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Shoulder Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study participants
- description
- Study participants will complete study related documents including a demographics questionnaire and the shoulder-related patient reported outcome measures.
- interventionNames
- Other: Questionnaires
Primary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEden 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. PMID 34174083