Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients

Conditions
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Solid Neoplasm

Intervention / Treatment
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* Device: Accelerometer
* Other: Laboratory Biomarker Analysis
* Other: Physical Activity Measurement
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational (physical activity, accelerometer, PROs)<br>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<br>* Wear Microsoft Band 2<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Physical Activity Measurement<br>* Perform physical activities recorded by Microsoft Kinect 2<br>* Other names: ACTIVITY;Behavioral: Telephone-Based Intervention<br>* Complete PRO questionnaires<br>|

What is the study measuring?
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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 |