Hematopoietic and Lymphatic System NeoplasmNCT07082257
Precision Performance Status Compared With ECOG Performance Status
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Southern California at 2 sites in United States.
Trial 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 (<… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Functional Assessment and Timed Get Up and Go Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Nov 2022to 22 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with appointments at University of Southern California (USC)/Norris Cancer Center
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Precision Performance Status Compared With ECOG Performance Status- A Pilot Cross Sectional Observational Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Functional Assessment, Timed Get Up and Go Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional AssessmentOther
Undergo chair-to-table assessment
Timed Get Up and Go TestBehavioural
Undergo "Get Up and Go" assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional Assessment; Behavioral: Timed Get Up and Go Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Video recording assessed ECOG Performance Status (PS) measurement
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start22 Nov 2022
- Primary completion28 May 2024
- Study completion22 May 2026
Why it stopped: Study is not progressing towards scientific goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jorge J Nieva, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082257
- Sponsor's protocol ID
- 0S-22-6
- Other IDs
- NCI-2022-09079, 0S-22-6, P30CA014089
- Status last verified
- May 2026
- First submitted
- 10 Jul 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Prasad A, Qi E, Pai J, Law J, Chennapan K, Jirka G, Kuhn P, Tale M, Nocera L, Nieva J. Augmenting Performance Status: A Preliminary Study of Objective Kinematic Assessment Using Motion Capture. Oncol Ther. 2026 Jun;14(2):735-747. doi: 10.1007/s40487-026-00434-x. Epub 2026 May 7.
PubMed 42098537
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Performance Status Compared With ECOG Performance Status- A Pilot Cross Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07082257
- Acronym / sponsor ID
- 0S-22-6
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study is not progressing towards scientific goals
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational ("Get Up and Go" and chair-to-table assessments) | – | Other: Functional Assessment, Behavioral: Timed Get Up and Go TestPatients undergo "Get Up and Go" assessment as well as a chair-to-table assessment during the clinic visit on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with appointments at University of Southern California (USC)/Norris Cancer Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional AssessmentUndergo chair-to-table assessment | Other | Observational ("Get Up and Go" and chair-to-table assessments) |
| Timed Get Up and Go TestUndergo "Get Up and Go" assessment | Behavioural | Observational ("Get Up and Go" and chair-to-table assessments) |
Primary outcome
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.
1 secondary outcome
Video recording assessed ECOG Performance Status (PS) measurement
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Study is not progressing towards scientific goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42098537Wang C, Prasad A, Qi E, Pai J, Law J, Chennapan K, Jirka G, Kuhn P, Tale M, Nocera L, Nieva J. Augmenting Performance Status: A Preliminary Study of Objective Kinematic Assessment Using Motion Capture. Oncol Ther. 2026 Jun;14(2):735-747. doi: 10.1007/s40487-026-00434-x. Epub 2026 May 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge J Nieva, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study is not progressing towards scientific goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median acceleration at the Spine Base and non-pivoting leg (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07082257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.