Clinical trial NCT03971266: Movement and Fitness Trackers in Determining Performance Status
Official title: Precision Performance Status Assessment in Early Phase Clinical Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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: 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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of non-hematologic serious adverse events (SAEs)
timeFrame: Up to 60 days
Secondary outcomes:
measure: The number of serious adverse events
timeFrame: Up to 60 days
measure: The probability of early trial discontinuation as determined by withdrawal from therapy
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jorge J Nieva, MD
role: PRINCIPAL_INVESTIGATOR
References: