Movement and Fitness Trackers in Determining Performance Status

NCT03971266 | Terminated DMC

• 3 other identifiers: 0S-18-8NCI-2019-02543P30CA014089
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 60 days

Secondary Outcomes (2)

• The number of serious adverse events

  Up to 60 days

• The probability of early trial discontinuation as determined by withdrawal from therapy

  Up to 30 days

Study Arms (1)

Prevention (Fitbit, PRO diary)

EXPERIMENTAL

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

Interventions

Activity Monitor OTHER

Wear a Fitbit

Also known as: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device

Prevention (Fitbit, PRO diary)

Media Intervention OTHER

Complete smartphone based PRO diary

Prevention (Fitbit, PRO diary)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fitness Trackers

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Jorge J Nieva, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: March 27, 2019
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (2)