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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (physical activity, PROs) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer | Other | Wear Microsoft Band 2 |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Nieva | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States | ||
| USC / Norris Comprehensive Cancer Center |
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| Laboratory Biomarker Analysis |
| Other |
Correlative studies |
|
| Physical Activity Measurement | Other | Perform physical activities recorded by Microsoft Kinect 2 |
|
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| Telephone-Based Intervention | Behavioral | Complete PRO questionnaires |
|
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 |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | 92663 | United States |
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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