Clinical trial NCT03098277: Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy
Official title: Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Solid Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-31
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients whose wearable activity monitor provides movement data
timeFrame: Up to 60 days
measure: 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
timeFrame: Up to 60 days
Secondary outcomes:
measure: Change in weight over time
timeFrame: Baseline to 60 days
Other outcomes:
measure: Patient in-office activity performance time assessed by Microsoft Kinect 2
timeFrame: Up to 60 days
measure: Presence of circulating tumor cells in blood
timeFrame: Day 21 (visit 2)
measure: Sum of inpatient and outpatient hospital encounters
timeFrame: Up to 90 days after study discontinuation
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: USC Norris Oncology/Hematology-Newport Beach
state: California
Study officials:
affiliation: University of Southern California
name: Jorge Nieva
role: PRINCIPAL_INVESTIGATOR
References: