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

Completed

• Conditions: Head and Neck Cancer
• Interventions: 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

• Registration Number: NCT01952821
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-21
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-09-30
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
FACIT-Fatigue	Baseline - 1 week

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States