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Activity Monitoring for Cancer Performance Status

N/A

Recruiting

Led By Jorge J Nieva, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate without an assistive device

Be older than 18 years old

Must not have

Missing lower limbs

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses movement and fitness trackers to see how well patients with cancer are doing. The trackers record things like steps, heart rate, and calories burned. This information can help doctors see which patients might have problems and need extra help.

Who is the study for?

This trial is for cancer patients who can walk unaided, are being screened for early phase clinical trials at USC/Norris, own a smartphone, and agree to wear activity trackers. They must understand English, Spanish or traditional Chinese. People with missing lower limbs, symptomatic brain metastases or severe movement disorders requiring medication cannot join.

What is being tested?

The study is testing if using fitness trackers to monitor physical activity and other metrics like heart rate can more accurately determine the performance status of cancer patients in clinical trials and predict risks for adverse events and hospitalization.

What are the potential side effects?

Since this trial involves non-invasive monitoring through wearable devices rather than drugs or medical procedures, there are no direct side effects from interventions. However, privacy concerns regarding GPS tracking might be considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without needing help from devices.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am missing one or both of my lower limbs.

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I have a severe movement disorder like Parkinson's that needs medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of non-hematologic serious adverse events (SAEs)

Secondary study objectives

The number of serious adverse events

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (Fitbit, PRO diary)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Activity Monitor

2013

N/A

~320

0 / 3Eligibility criteria met