Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

NCT03098277 | Completed DMC

• 3 other identifiers: 0S-16-2NCI-2016-00627P30CA014089
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in weight over time

  Baseline to 60 days

Other Outcomes (3)

• Patient in-office activity performance time assessed by Microsoft Kinect 2

  Up to 60 days

• Presence of circulating tumor cells in blood

  Day 21 (visit 2)

• Sum of inpatient and outpatient hospital encounters

  Up to 90 days after study discontinuation

Study Arms (1)

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.

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

Interventions

Accelerometer OTHER

Wear Microsoft Band 2

Observational (physical activity, PROs)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (physical activity, PROs)

Physical Activity Measurement OTHER

Perform physical activities recorded by Microsoft Kinect 2

Also known as: ACTIVITY

Observational (physical activity, PROs)

Telephone-Based Intervention BEHAVIORAL

Complete PRO questionnaires

Observational (physical activity, PROs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jorge Nieva

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: March 31, 2017
• Study Start: May 6, 2016
• Primary Completion: March 12, 2018
• Study Completion: February 6, 2019
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (3)