Clinical trial · Interventional
Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy
RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck 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)
This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.
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 |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitoring Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device Feasibility (Fitbit Charge 3)
- description
- Participants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course.
- interventionNames
- Device: Monitoring Device
Primary outcomes (1)
- measure
- Percentage of time patients wear the Fitbit Charge 3 device (compliance)
- timeFrame
- Through study completion, an average of 3 months
- description
- Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects have head and neck cancer as defined in history and physical * Patients are eligible to be treated with RT or CRT and plan to start treatment * Patients are capable of giving informed consent * Patients must be able to read and/or to speak English * Patients who are 18 years of age or older * Women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation CT planning scan Exclusion Criteria: * Patients who cannot read or speak English * Patients who are not candidates for RT/CRT treatment. * Women of childbearing potential who are pregnant or breastfeeding
References
Publications (0)
Data not yet available