Solid NeoplasmNCT03098277
Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy
A study testing Accelerometer, Laboratory Biomarker Analysis and Physical Activity Measurement in people with Solid Neoplasm, run by University of Southern California at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Neoplasm
- What is being tested?
- Accelerometer, Laboratory Biomarker Analysis and Physical Activity Measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 May 2016to 6 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
About this study
Official title: Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Solid Neoplasm
- Being tested
- Accelerometer, Laboratory Biomarker Analysis, Physical Activity Measurement, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerOther
Wear Microsoft Band 2
Laboratory Biomarker AnalysisOther
Correlative studies
Physical Activity MeasurementOther
Also called ACTIVITY
Perform physical activities recorded by Microsoft Kinect 2
Telephone-Based InterventionBehavioural
Complete PRO questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Accelerometer; Other: Laboratory Biomarker Analysis; Other: Physical Activity Measurement; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose wearable activity monitor provides movement data
Measured: 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.
Measured: Up to 60 days
Secondary outcomes (1)
Change in weight over time
The relationship between the change in weight over time and patient activity
Measured: Baseline to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start6 May 2016
- Primary completion12 Mar 2018
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jorge Nieva, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098277
- Sponsor's protocol ID
- 0S-16-2
- Other IDs
- NCI-2016-00627, 0S-16-2, P30CA014089
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2016
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients
- ClinicalTrials.gov ID
- NCT03098277
- Acronym / sponsor ID
- 0S-16-2
- Conditions
- Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 May 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (physical activity, PROs) | Experimental | Other: Accelerometer, Other: Laboratory Biomarker Analysis, Other: Physical Activity Measurement, Behavioral: Telephone-Based InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerWear Microsoft Band 2 | Other | Observational (physical activity, PROs) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Observational (physical activity, PROs) |
| Physical Activity MeasurementAlso: ACTIVITYPerform physical activities recorded by Microsoft Kinect 2 | Other | Observational (physical activity, PROs) |
| Telephone-Based InterventionComplete PRO questionnaires | Behavioural | Observational (physical activity, PROs) |
Primary outcome
Percentage of patients whose wearable activity monitor provides movement data
Time frame: 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
Time frame: Up to 60 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.
1 secondary outcome
Change in weight over time
Time frame: Baseline to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Related trials for Solid Neoplasm
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Nieva principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer, Laboratory Biomarker Analysis and Physical Activity Measurement in people with Solid Neoplasm, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients whose wearable activity monitor provides movement data (time frame: Up to 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.