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

NCT02554968 | Completed

• 1 other identifier: 15-005266
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 3

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.

Conditions

Shoulder Pain; Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• Disability of the Arm, Shoulder and Hand

  One day

• QuickDASH

  One day

• Shoulder Pain and Disability Index

  One day

• University of Washington Quality of Life Scale (shoulder-subscale)

  One day

• Neck Dissection Impairment Index

  One day

Study Arms (1)

Study participants

Study participants will complete study related documents including a demographics questionnaire and the shoulder-related patient reported outcome measures.

Other: Questionnaires

Interventions

Questionnaires OTHER

Study participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients reporting shoulder discomfort, stiffness or weakness following a neck dissection procedure for management of head and neck cancer.

You may qualify if:

• 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?")
• years of age
• Adequate fluency in the English language to complete the study-related forms and questionnaires

You may not qualify if:

• No reported shoulder impairment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Eden 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 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, DPT, OCS

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

US (3)