Precision Performance Status Compared With ECOG Performance Status

NCT ID: NCT07082257

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2026-05-28

Brief Summary

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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

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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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Functional Assessment

Intervention Type OTHER

Undergo chair-to-table assessment

Timed Get Up and Go Test

Intervention Type BEHAVIORAL

Undergo "Get Up and Go" assessment

Interventions

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Functional Assessment

Undergo chair-to-table assessment

Intervention Type OTHER

Timed Get Up and Go Test

Undergo "Get Up and Go" assessment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge J Nieva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2022-09079

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-22-6

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0S-22-6

Identifier Type: -

Identifier Source: org_study_id

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