Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
Undergo chair-to-table assessment
BEHAVIORALTimed Get Up and Go Test
Undergo "Get Up and Go" assessment
Sponsors
University of Southern California
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median acceleration at the Spine Base and non-pivoting leg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Video recording assessed ECOG Performance Status (PS) measurement | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJorge J Nieva, MD
University of Southern California
Outcome results
None listed