Clinical trial · Observational
Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer
The Biosensor Study: Exploratory Study Evaluating the Use of Wearable Biosensors and Patient Reported Outcomes (PROs) to Assess Performance Status and Distress in Patients With Cancer
- 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 evaluate the association between wearable biosensor data, performance status and patient-reported outcomes in cancer patients. Participants in this study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires that will assess patient reported outcome measures including physical function, emotional distress, pain interference, sleep disturbance and fatigue. Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18 years of age and be English speaking due to the questionnaires that will be administered during the study. Patients must also be ambulatory (use of walking aids, such as cane and rollator, is acceptable) and have access to a smartphone with internet access (IOS or Android). It is also necessary for patients to have scheduled oncology clinic visits at least once every 2 weeks.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Charge HR® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biosensor + Patient Reported Outcomes (PRO)
- description
- Participants will wear a biosensor (Fitbit Charge HR®) continuously for a period of 15 days and respond to PROMIS questionnaires. This is not a chemotherapy or treatment-intervention trial.
- interventionNames
- Device: Fitbit Charge HR®
Primary outcomes (4)
- measure
- Physical activity as measured using Fitbit Charge HR (composite of mean daily steps and stairs per day, mean resting heart rate, mean daily active minutes and time sedentary, stairs climbed)
- timeFrame
- 15 days
- description
- Data will be compared to reference standards to answer primary objective.
- measure
- Performance status as measured with with Eastern Cooperative Oncology Group performance status (ECOG-PS) scale
- timeFrame
- 15 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of advanced solid malignancy (Stage 3 or 4) with measurable disease, who are being followed by an oncologist * 18 years or older * English speaking * Ambulatory (use of walking aids, such as cane and rollator, is acceptable) * Access to IOS or Android smartphone with internet access * Expected to have oncology clinic visits at least once every 2 weeks * Have an understanding, ability, and willingness to fully comply with study procedures and restrictions * Ability to consent Exclusion Criteria: * Allergy to surgical steel or elastomer/rubber * Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment
References
Publications (0)
Data not yet available