Precision Performance Status Compared With ECOG Performance Status

University of Southern California

Status: Active, not recruiting

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07082257

0S-22-6 (Other Identifier)

NCI-2022-09079 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 1 patient group

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

Description:

Patients undergo "Get Up and Go" assessment as well as a chair-to-table assessment during the clinic visit on study.

Treatment:

Other: Functional Assessment

Behavioral: Timed Get Up and Go Test