Clinical trial · Observational
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer, Metastatic | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable activity monitor | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Wearable activity monitor
- description
- Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
- interventionNames
- Other: Wearable activity monitor
Primary outcomes (2)
- measure
- Absolute change in average step counts at 8 weeks from baseline
- timeFrame
- 8 weeks
- description
- Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit
- measure
- Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
- timeFrame
- 8 weeks
- description
- Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of advanced (stage 3 or 4) cancer of any type * Ambulatory (use of walking aids, such as cane and rollator, is acceptable) * Access to a device that has the capability to sync to the Fitbit * Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days). * Have an understanding, ability, and willingness to fully comply with study procedures and restrictions * English or Spanish speaking * Ability to consent * Informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Allergy to surgical steel or elastomer/rubber * Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
References
Publications (0)
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