CancerNCT00735111
Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?
A study testing Karnofsky Performance Status Score in people with Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Karnofsky Performance Status Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2011
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of brain or spinal tumor.
- Receiving medical care under the supervision of the Principal Investigator.
- Written informed consent.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores?
The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.
Read the detailed description
The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.
- Conditions
- Cancer
- Being tested
- Karnofsky Performance Status Score
- Keywords
- QOL, Quality of Life, KPS, Karnofsky Performance Status, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karnofsky Performance Status ScoreOther
Also called Performance Status Scale
Karnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Karnofsky Performance Status Score | Experimental | Not described Receives: Other: Karnofsky Performance Status Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin M Dunbar, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735111
- Sponsor's protocol ID
- QOL-001
- Status last verified
- Jan 2013
- First submitted
- 13 Aug 2008
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores?
- ClinicalTrials.gov ID
- NCT00735111
- Acronym / sponsor ID
- QOL-001
- Conditions
- Cancer
- Keywords
- QOL, Quality of Life, KPS, Karnofsky Performance Status, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Aug 2008 (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 determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.
Detailed description
The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Karnofsky Performance Status Score | Experimental | Other: Karnofsky Performance Status Score |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of brain or spinal tumor.
- Receiving medical care under the supervision of the Principal Investigator.
- Written informed consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Karnofsky Performance Status ScoreAlso: Performance Status ScaleKarnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit. | Other | Karnofsky Performance Status Score |
Primary outcome
To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores.
Time frame: 2 Years
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 17 Jan 2013.
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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.
Erin M Dunbar, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karnofsky Performance Status Score in people with Cancer, run by University of Florida 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 3 inclusion and 1 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 17 Jan 2013. 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?
To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores. (time frame: 2 Years). 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 17 Jan 2013.