Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck

The Validity and Reliability of the Six-Minute Walk Test, Ten-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modified Brief Fatigue Inventory in Patients With Cancer of the Head and Neck

The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory as reliable and valid outcome measurements for patients with head and neck cancer.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Six-Minute Walk Test; Other: 10-Meter Walk Test; Other: 30-Second Chair Stand; Other: Linear Analog Scale of Function; Other: Modified Brief Fatigue Inventory; Other: FACIT-Fatigue

Detailed Description

This study will be looking at the test-retest reliability and validity of various outcome measures in patients with cancer of the head and neck. Testing will occur in 2 visits within one week.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling patients with a new or recurrent diagnosis of head and neck cancer.

Description

Inclusion Criteria:

• Age 18-85
• Within 3 months of surgery, or are currently undergoing radiation and/or chemotherapy for a diagnosis of head and neck cancer
• Community dwelling
• Able to provide informed consent, answer relevant questionnaires,follow instructions provided during testing

Exclusion Criteria:

• Vulnerable populations (minors, prisoners)
• Medical comorbidities which limit the safe completion of the 6MWT, gait speed, and strength testing
• Inability to return for a second day of testing within one week

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test Group; This group will receive all listed outcome measures on 2 testing visits.	Other: Six-Minute Walk Test; Other: 10-Meter Walk Test; Other: 30-Second Chair Stand; Other: Linear Analog Scale of Function; Other: Modified Brief Fatigue Inventory; Other: FACIT-Fatigue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Six-Minute Walk Test	Baseline - 1 week
10-Meter Walk Test	Baseline - 1 week
30-Second Chair Stand	Baseline - 1 week
Linear Analog Scale of Function	Baseline - 1 week
Modified Brief Fatigue Inventory	Baseline - 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
FACIT-Fatigue	Baseline - 1 week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Nova Southeastern University
• Investigators: Principal Investigator: Melissa M. Eden, DPT, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 21, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (Estimate): September 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Gait Speed; Physical function; 6MWT; Cancer Related Fatigue; 10-Meter Walk Test; 30-Second Chair Stand; Linear Analog Scale of Function; Modified Brief Fatigue Inventory
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 13-004891