Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients

This clinical trial studies movement tracking devices in optimizing and monitoring physical activity in patients with solid tumors undergoing chemotherapy in a health care facility during the day without spending the night. Movement tracking devices, such as Microsoft Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.

Study Overview

• Status: Completed
• Conditions: Solid Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Physical Activity Measurement; Behavioral: Telephone-Based Intervention; Other: Accelerometer

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.

SECONDARY OBJECTIVES:

I. To evaluate the association between activity and patient reported fatigue. II. To evaluate the association between movement and incidents of health care interventions (hospitalizations, physical visits, intravenous hydration, etc.)

TERTIARY OBJECTIVES:

I. To compare physician and patient assessed Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status scores with the data obtained from movement trackers.

OUTLINE:

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based patient reported outcome (PRO) questionnaire, and weigh themselves daily for 60 days.

After completion of study, patients are followed up at 90 days.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Los Angeles County-USC Medical Center
    • Newport Beach, California, United States, 92663
      • USC Norris Oncology/Hematology-Newport Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A diagnosis of a solid tumor, undergoing palliative or adjuvant therapy
• Undergoing at least 2 planned cycles of highly emetogenic chemotherapy defined according to the Hekseth scale; the cycles may range in duration from 14 days to 28 days, according to standard of care practices
• Ability to understand and the willingness to sign a written informed consent
• Willingness to wear sensors to track physical activity, Global Positioning System (GPS) location, and provide symptom ratings each night for up to 60 days
• Able to read English, Spanish, or Traditional Mandarin to complete patient reported outcomes
• Able to ambulate without an assistive device
• Able to operate a smartphone and wearable wristband

Exclusion Criteria:

• Patients may not be missing limbs
• Patient does not have a diagnosis of a hematologic malignancy
• Patients with symptomatic brain metastases are excluded from this clinical trial; those with asymptomatic brain metastasis are permitted; it is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis
• Patient with a 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Observational (physical activity, PROs); Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based PRO questionnaire, and weigh themselves daily for 60 days.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Physical Activity Measurement; Perform physical activities recorded by Microsoft Kinect 2; Other Names: ACTIVITY; Behavioral: Telephone-Based Intervention; Complete PRO questionnaires; Other: Accelerometer; Wear Microsoft Band 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients whose wearable activity monitor provides movement data		Up to 60 days
Percent of patients who achieve "data capture success" defined as having both PRO data and accelerometry data transmitted to the investigators in 80% of the observation days	Patients who are unable to comply and have data transmitted, including technical failures, personal decision, hospitalization, or any other reason are counted as "data capture failures". Data from patients who die while on study will not be replaced but will be included prior to their date of death, days between death and day 60 will not be included in the denominator when calculating "data capture success" rates.	Up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight over time	The relationship between the change in weight over time and patient activity	Baseline to 60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient in-office activity performance time assessed by Microsoft Kinect 2	The association between the "get up and go" time and moving onto the examination table will be explored.	Up to 60 days
Presence of circulating tumor cells in blood	The association between the presence of circulating tumor cells and patient activity will be explored.	Day 21 (visit 2)
Sum of inpatient and outpatient hospital encounters	The association between patient movement and the sum of inpatient and outpatient hospital encounters up to 90 days after study discontinuation will be explored.	Up to 90 days after study discontinuation

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jorge Nieva, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2016
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): February 6, 2019

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: March 25, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0S-16-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2016-00627 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No