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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can walk on my own without needing help from devices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of non-hematologic serious adverse events (SAEs)
Secondary outcome measures
The number of serious adverse events
The probability of early trial discontinuation as determined by withdrawal from therapy
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,938 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,220 Total Patients Enrolled
Jorge J Nieva, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk on my own without needing help from devices.I am being screened for a USC/Norris clinical trial.I have been diagnosed with cancer.I have brain metastases but no symptoms, or I am on steroids for them.I can read English, Spanish, or traditional Chinese to fill out health forms.I am missing one or both of my lower limbs.I have a severe movement disorder like Parkinson's that needs medication.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (Fitbit, PRO diary)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this clinical experiment?
"Affirmative, the information on clinicaltrials.gov indicates that enrolment for this investigation is ongoing. It was initial published in March 2019 and recently updated in August 2022. The study has a quota of 68 participants across three separate sites."
Answered by AI
How many individuals are currently enrolled in this clinical trial?
"Affirmative. The details available on clinicaltrials.gov indicates that the trial is currently recruiting participants, having initially been posted on March 27th 2019 and recently updated on August 5th 2021. 68 volunteers must be recruited from 3 different locations."
Answered by AI
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