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| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2008 | ||||
| Last Updated Date | August 11, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores. [ Time Frame: 5 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00735111 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores? | ||||
| Official Title ICMJE | Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores? | ||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Non-Randomized, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Other: Karnofsky Performance Status Score | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None. |
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00735111 | ||||
| Responsible Party | Erin M. Dunbar, MD, University of Florida | ||||
| Study ID Numbers ICMJE | QOL-001 | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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