Movement and Fitness Trackers in Determining Performance Status
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03971266 |
Recruitment Status :
Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Neoplasm | Device: Activity Monitor Other: Media Intervention | Not Applicable |
PRIMARY OBJECTIVES:
I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials.
SECONDARY OBJECTIVES:
Secondary objectives are related to outpatient activity trackers. I. To determine the association between the occurrence of SAEs and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit.
II. To determine the association between the occurrence of SAEs and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of EDT.
III. To determine the association between the occurrence of SAEs and early trial termination, with averaged activity level classification in the first 4 weeks of the EDT.
OUTLINE:
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based Patient Reported Outcomes (PRO) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Precision Performance Status Assessment in Early Phase Clinical Trials |
Actual Study Start Date : | March 27, 2019 |
Estimated Primary Completion Date : | March 27, 2021 |
Estimated Study Completion Date : | March 27, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Prevention (Fitbit, PRO diary)
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based PRO diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
|
Device: Activity Monitor
Wear a Fitbit
Other Name: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device Other: Media Intervention Complete smartphone based PRO diary |
- Incidence of non-hematologic serious adverse events (SAEs) [ Time Frame: Up to 60 days ]SAEs are the grade 3 or 4 non-hematologic toxicities based on CTCAE 4.0 and documented in each therapeutic clinical trials that participants were treated on. Logistic regression will be used to test the association of average measurements of Get-up and Go, and Kinect assessments collected from screening visit day (visit 1) and the first day of Early and Developmental Therapeutics (EDT) trial (visit 2) with the occurrence of SAEs after EDT given, especially during the first 60 days on EDT trial.
- The number of serious adverse events [ Time Frame: Up to 60 days ]Will use logistic regression and correlation tests to test the association of outpatient movement ability classified based on metabolic equivalents (METS) collected from the first 7 days after visit 1 (baseline measurement) with the occurrence of SAEs after EDT given, and early trial determination; the correlation of activity hours and METS in the first 7 days after Visit 1 with number of SAEs observed will be tested.
- The probability of early trial discontinuation as determined by withdrawal from therapy [ Time Frame: Up to 30 days ]Early termination is defined as cancer treatment discontinued within the first 30 days of EDT trial.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A diagnosis of cancer.
- Undergoing screening for a University of Southern California (USC)/Norris therapeutic clinical trial operated by the Early and Developmental Therapeutics Program which includes both phase I and II clinical trials.
- Owns a smartphone.
- 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 during the screening period of their clinical trial and 180 days after starting treatments.
- Able to read English, Spanish, or traditional Chinese to complete patient reported outcomes.
- Able to ambulate without an assistive device.
Exclusion Criteria:
- Missing lower limbs.
- Symptomatic brain metastases are excluded from this clinical trial. However, those with asymptomatic brain metastasis are permitted. It is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971266
United States, California | |
Los Angeles County-USC Medical Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Aaron E. Mejia 323-409-4355 aaron.mejia@med.usc.edu | |
Principal Investigator: Jorge J. Nieva | |
USC / Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Aaron E. Mejia 323-409-4355 aaron.mejia@med.usc.edu | |
Principal Investigator: Jorge J. Nieva | |
Hoag Memorial Hospital | Recruiting |
Newport Beach, California, United States, 92663 | |
Contact: Cristina de Leon 949-764-5543 cristina.deleon@hoag.org | |
Principal Investigator: Diana L. Hanna |
Principal Investigator: | Jorge J Nieva | University of Southern California |
Responsible Party: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT03971266 |
Other Study ID Numbers: |
0S-18-8 NCI-2019-02543 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 0S-18-8 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
First Posted: | June 3, 2019 Key Record Dates |
Last Update Posted: | June 3, 2019 |
Last Verified: | May 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Neoplasms |