Head and Neck Cancer Clinical Trial
Official title:
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
Verified date | May 2015 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | January 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Nova Southeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six-Minute Walk Test | Baseline - 1 week | No | |
Primary | 10-Meter Walk Test | Baseline - 1 week | No | |
Primary | 30-Second Chair Stand | Baseline - 1 week | No | |
Primary | Linear Analog Scale of Function | Baseline - 1 week | No | |
Primary | Modified Brief Fatigue Inventory | Baseline - 1 week | No | |
Secondary | FACIT-Fatigue | Baseline - 1 week | No |
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