NCT01952821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

September 21, 2013

Last Update Submit

May 21, 2015

Conditions

Head and Neck Cancer

Keywords

Head and Neck CancerPhysical functionCancer Related FatigueGait Speed6MWT10-Meter Walk Test30-Second Chair StandLinear Analog Scale of FunctionModified Brief Fatigue Inventory

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • FACIT-Fatigue

    Baseline - 1 week

Study Arms (1)

Test Group

This group will receive all listed outcome measures on 2 testing visits.

Other: Six-Minute Walk TestOther: 10-Meter Walk TestOther: 30-Second Chair StandOther: Linear Analog Scale of FunctionOther: Modified Brief Fatigue InventoryOther: FACIT-Fatigue

Interventions

Six-Minute Walk TestOTHER
Test Group
10-Meter Walk TestOTHER
Test Group
30-Second Chair StandOTHER
Test Group
Linear Analog Scale of FunctionOTHER
Test Group
Modified Brief Fatigue InventoryOTHER
Test Group
FACIT-FatigueOTHER
Test Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Melissa M. Eden, DPT

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

September 21, 2013

First Posted

September 30, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

US(1)