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Completed

NCT Number: NCT01952821

Validity and Reliability of Outcome Measures 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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. Six-Minute Walk Test

    Time frame: Baseline - 1 week

  2. 10-Meter Walk Test

    Time frame: Baseline - 1 week

  3. 30-Second Chair Stand

    Time frame: Baseline - 1 week

  4. Linear Analog Scale of Function

    Time frame: Baseline - 1 week

  5. Modified Brief Fatigue Inventory

    Time frame: Baseline - 1 week

Secondary outcomes

  1. FACIT-Fatigue

    Time frame: Baseline - 1 week

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Nova Southeastern University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 30, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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