- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07082257
- Original Trial
Precision Performance Status Compared With ECOG Performance Status
Precision Performance Status Compared With ECOG Performance Status- A Pilot Cross Sectional Observational Study
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the correlation between patient acceleration of the spine base/non-pivoting leg captured with in-office movement trackers, and physician/patient assessed Eastern Cooperative Oncology Group (ECOG) performance status (PS) using a Microsoft Kinect movement tracker.
SECONDARY OBJECTIVES:
I. To determine the correlation between clinician/patient assessed ECOG PS and Kinect assessed ECOG PS score.
II. To determine the range of measured patient acceleration measurements for each ECOG score between 0 and 3.
OUTLINE: This is an observational study.
Patients undergo "Get Up and Go" assessment as well as a chair-to-table assessment during the clinic visit on study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90033
- Los Angeles General Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- A diagnosis of cancer
- Age >= 18 years
- Ability to understand and the willingness to sign a written informed consent
- Able to ambulate without an assistive device
Exclusion Criteria:
- Missing lower limbs
- Known movement disorder such as Parkinson's disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational ("Get Up and Go" and chair-to-table assessments)
Patients undergo "Get Up and Go" assessment as well as a chair-to-table assessment during the clinic visit on study.
|
Undergo chair-to-table assessment
Undergo "Get Up and Go" assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median acceleration at the Spine Base and non-pivoting leg
Time Frame: Day 1
|
The Kinect device will record the participant performing the chair to examination table activity and the Get up and Go activity.
This recording will quantify spine and non-pivoting leg mean acceleration during movement onto an examination table and the Get up and Go time.
These values will be assessed for a linear or monotonic relationship with Eastern Cooperative Oncology Group (ECOG) scores.
If a linear relationship is exhibited the primary objective will be evaluated via a Pearson correlation coefficient.
However, the supposition is the data will more likely reflect a monotonic relationship.
In this event the primary objective will be evaluated via a Kendall Rank Tau-b correlation coefficient.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Video recording assessed ECOG Performance Status (PS) measurement
Time Frame: Baseline
|
The relationship between ECOG PS determined subjectively in clinic and ECOG PS determined by reviewing the Kinect recording will be assessed for a linear or monotonic relationship.
However, the supposition is a linear relationship is more likely.
A Pearson or Kendall Rank correlation will be utilized accordingly to evaluate a correlation.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jorge J Nieva, MD, University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0S-22-6 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2022-09079 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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