Precision Performance Status Assessment in Early Phase Clinical Trials
Description
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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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.
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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