Clinical trial · Interventional
Movement and Fitness Trackers in Determining Performance Status
Precision Performance Status Assessment in Early Phase Clinical Trials
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity Monitor | Other | — | UNRESOLVED |
| Media Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (Fitbit, PRO diary)
- description
- 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.
- interventionNames
- Other: Activity Monitor
- Other: Media Intervention
Primary outcomes (1)
- measure
- Incidence of non-hematologic serious adverse events (SAEs)
- timeFrame
- Up to 60 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available