An interventional study of Activity Monitor and Media Intervention in Malignant Neoplasm, sponsored by University of Southern California. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by University of Southern California · Not applicable, Interventional, and Other
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
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.
Other: Activity Monitor · Other: Media Intervention
Wear a Fitbit
Also known as: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device
Complete smartphone based PRO diary
Incidence of non-hematologic serious adverse events (SAEs)
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.
Time frame: Up to 60 days
The number of serious adverse events
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.
Time frame: Up to 60 days
The probability of early trial discontinuation as determined by withdrawal from therapy
Early termination is defined as cancer treatment discontinued within the first 30 days of EDT trial.
Time frame: Up to 30 days
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Southern California