Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

Solid Neoplasm Clinical Trial

Official title:

Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03098277
• Other study ID #: 0S-16-2
• Secondary ID: NCI-2016-006270S
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2016
• Est. completion date: December 6, 2024

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: December 6, 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Neoplasm

Intervention

Device:
• Accelerometer
Wear Microsoft Band 2

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Physical Activity Measurement
Perform physical activities recorded by Microsoft Kinect 2

Behavioral:
• Telephone-Based Intervention
Complete PRO questionnaires

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	USC Norris Oncology/Hematology-Newport Beach	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Presence of circulating tumor cells in blood	The association between the presence of circulating tumor cells and patient activity will be explored.	Day 21 (visit 2)
Other	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
Primary	Percentage of patients whose wearable activity monitor provides movement data		Up to 60 days
Primary	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	Change in weight over time	The relationship between the change in weight over time and patient activity	Baseline to 60 days