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Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098277
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Neoplasm Device: Accelerometer Other: Laboratory Biomarker Analysis Other: Physical Activity Measurement Behavioral: Telephone-Based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.
Device: Accelerometer
Wear Microsoft Band 2

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Physical Activity Measurement
Perform physical activities recorded by Microsoft Kinect 2
Other Name: ACTIVITY

Behavioral: Telephone-Based Intervention
Complete PRO questionnaires




Primary Outcome Measures :
  1. Percentage of patients whose wearable activity monitor provides movement data [ Time Frame: Up to 60 days ]
  2. 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.


Secondary Outcome Measures :
  1. Change in weight over time [ Time Frame: Baseline to 60 days ]
    The relationship between the change in weight over time and patient activity


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jorge Nieva University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03098277    
Other Study ID Numbers: 0S-16-2
NCI-2016-00627 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-16-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes