Head and Neck CancerNCT01952821
Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck
An observational study of Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Six-Minute Walk Test, 10-Meter Walk Test and 30-Second Chair Stand
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling patients with a new or recurrent diagnosis of head and neck cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Six-Minute Walk Test, 10-Meter Walk Test, 30-Second Chair Stand, Linear Analog Scale of Function, Modified Brief Fatigue Inventory
- Keywords
- Head and Neck Cancer, Physical function, Cancer Related Fatigue, Gait Speed, 6MWT, 10-Meter Walk Test, 30-Second Chair Stand, Linear Analog Scale of Function, Modified Brief Fatigue Inventory
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-Minute Walk TestOther
10-Meter Walk TestOther
30-Second Chair StandOther
Linear Analog Scale of FunctionOther
Modified Brief Fatigue InventoryOther
FACIT-FatigueOther
| Study group | Role | What they receive |
|---|---|---|
| Test Group | This group will receive all listed outcome measures on 2 testing visits. Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
Measured: Baseline - 1 week
10-Meter Walk Test
Measured: Baseline - 1 week
30-Second Chair Stand
Measured: Baseline - 1 week
Linear Analog Scale of Function
Measured: Baseline - 1 week
Modified Brief Fatigue Inventory
Measured: Baseline - 1 week
Secondary outcomes (1)
FACIT-Fatigue
Measured: Baseline - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Southeastern University
- Responsible party
- Principal investigator, Melissa M. Eden, Mayo Clinic
- Investigators
- Melissa M. Eden, DPT, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952821
- Sponsor's protocol ID
- 13-004891
- Status last verified
- May 2015
- First submitted
- 21 Sep 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01952821
- Acronym / sponsor ID
- 13-004891
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Physical function, Cancer Related Fatigue, Gait Speed, 6MWT, 10-Meter Walk Test, 30-Second Chair Stand, Linear Analog Scale of Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Nova Southeastern University
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | 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-FatigueThis group will receive all listed outcome measures on 2 testing visits. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling patients with a new or recurrent diagnosis of head and neck cancer.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six-Minute Walk Test | Other | Test Group |
| 10-Meter Walk Test | Other | Test Group |
| 30-Second Chair Stand | Other | Test Group |
| Linear Analog Scale of Function | Other | Test Group |
| Modified Brief Fatigue Inventory | Other | Test Group |
| FACIT-Fatigue | Other | Test Group |
Primary outcome
Six-Minute Walk Test
Time frame: Baseline - 1 week
10-Meter Walk Test
Time frame: Baseline - 1 week
30-Second Chair Stand
Time frame: Baseline - 1 week
Linear Analog Scale of Function
Time frame: Baseline - 1 week
Modified Brief Fatigue Inventory
Time frame: Baseline - 1 week
1 secondary outcome
FACIT-Fatigue
Time frame: Baseline - 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa M. Eden, DPT principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (time frame: Baseline - 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.