Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-02 @ 4:44 AM
Study NCT ID:
NCT07082257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Performance Status Compared With ECOG Performance Status
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Precision Performance Status Compared With ECOG Performance Status- A Pilot Cross Sectional Observational Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares consumer movement trackers to the Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) in monitoring cancer patient movement. The ECOG PS emphasizes a patient's ambulatory status (ability to walk around), and scores patients on a scale of 0-5: 0 (no restrictions), 1 (ambulatory), 2 (\< 50% of hours spent in bed, unable to carry out work activities), 3 (\> 50% of hours spent in bed, limited in self care), 4 (bedbound and gravely disabled) and 5 (deceased). Accurate assessment of a patient's PS is paramount in informing therapeutic decision-making, whether it be to predict response and tolerability to treatment or determine eligibility for clinical trials. However, the ECOG PS scale is observational, and therefore limited in its precision. Information gained in this study may help researchers learn if there is a better way to assess patient movement with computerized analysis tools using movement trackers.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-09079 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 0S-22-6 | OTHER | USC / Norris Comprehensive Cancer Center | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |