A Study of the Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-005266
- Scottsdale/Phoenix, Arizona: 15-005266
NCT ID: NCT02554968
Sponsor Protocol Number: 15-005266
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Melissa Eden, Ph.D., P.T., D.P.T. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Melissa Eden, Ph.D., P.T., D.P.T. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available