Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03098277|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Neoplasm||Device: Accelerometer Other: Laboratory Biomarker Analysis Other: Physical Activity Measurement Behavioral: Telephone-Based Intervention||Not Applicable|
I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.
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.)
I. To compare physician and patient assessed Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status scores with the data obtained from movement trackers.
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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients|
|Actual Study Start Date :||May 6, 2016|
|Estimated Primary Completion Date :||June 6, 2020|
|Estimated Study Completion Date :||December 6, 2021|
Experimental: Observational (physical activity, accelerometer, 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.
Wear Microsoft Band 2
Other: Laboratory Biomarker Analysis
Other: Physical Activity Measurement
Perform physical activities recorded by Microsoft Kinect 2
Other Name: ACTIVITY
Behavioral: Telephone-Based Intervention
Complete PRO questionnaires
- Percentage of patients whose wearable activity monitor provides movement data [ Time Frame: 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 [ Time Frame: Up to 60 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.
- Change in weight over time [ Time Frame: Baseline to 60 days ]The relationship between the change in weight over time and patient activity
- Patient in-office activity performance time assessed by Microsoft Kinect 2 [ Time Frame: Up to 60 days ]The association between the "get up and go" time and moving onto the examination table will be explored.
- Presence of circulating tumor cells in blood [ Time Frame: Day 21 (visit 2) ]The association between the presence of circulating tumor cells and patient activity will be explored.
- Sum of inpatient and outpatient hospital encounters [ Time Frame: Up to 90 days after study discontinuation ]The association between patient movement and the sum of inpatient and outpatient hospital encounters up to 90 days after study discontinuation will be explored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098277
|United States, California|
|Los Angeles County-USC Medical Center|
|Los Angeles, California, United States, 90033|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|USC Norris Oncology/Hematology-Newport Beach|
|Newport Beach, California, United States, 92663|
|Principal Investigator:||Jorge Nieva||University of Southern California|