Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

University of Southern California

Status: Completed

Conditions: Solid Neoplasm

Treatments: Behavioral: Telephone-Based Intervention; Other: Accelerometer; Other: Laboratory Biomarker Analysis; Other: Physical Activity Measurement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03098277

NCI-2016-00627 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

0S-16-2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Observational (physical activity, PROs)

Experimental group

Description:

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.

Treatment:

Other: Physical Activity Measurement

Other: Laboratory Biomarker Analysis

Other: Accelerometer

Behavioral: Telephone-Based Intervention