Precision Performance Status Compared With ECOG Performance Status

NCT07082257 | Active Not Recruiting DMC

• 3 other identifiers: 0S-22-6NCI-2022-09079P30CA014089
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Median acceleration at the Spine Base and non-pivoting leg

  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 Outcomes (1)

• Video recording assessed ECOG Performance Status (PS) measurement

  Baseline

Study Arms (1)

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.

Other: Functional Assessment; Behavioral: Timed Get Up and Go Test

Interventions

Functional Assessment OTHER

Undergo chair-to-table assessment

Observational ("Get Up and Go" and chair-to-table assessments)

Timed Get Up and Go Test BEHAVIORAL

Undergo "Get Up and Go" assessment

Observational ("Get Up and Go" and chair-to-table assessments)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with appointments at University of Southern California (USC)/Norris Cancer Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Study Officials

• Jorge J Nieva, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 24, 2025
• Study Start: November 22, 2022
• Primary Completion: May 28, 2024
• Study Completion (Estimated): May 28, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (2)