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Movement and Fitness Trackers in Determining Performance Status

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ClinicalTrials.gov Identifier: NCT03971266
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. Movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. The use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Device: Activity Monitor Other: Media Intervention Not Applicable

Detailed Description:

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.

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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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jorge J Nieva University of Southern California
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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

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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
Additional relevant MeSH terms:
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Neoplasms