Clinical trial · Interventional
Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
Wearable-Triggered Digital Safety Net for Real-Time Monitoring and Intervention in Leptomeningeal Metastasis
- 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 research study is for participants diagnosed with leptomeningeal metastasis disease (LMM), a condition where cancer has spread to the fluid and membranes surround the brain and spinal cord. The purpose of this study is to find out whether a consumer Smartwatch can continuously monitor the participant's health and detect early signs of neurological decline and whether sending an automatic alert to the participant's doctor when a change is detected can help reduce the number of participant hospitalizations.
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 |
|---|---|---|---|
| Leptomeningeal Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calibration Phase | Device | — | UNRESOLVED |
| Stepped Wedge Intervention Phase | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A - Crossover at month 2
- description
- Participants cross-over to Stepped Wedge Intervention Phase at month 2.
- interventionNames
- Device: Calibration Phase
- Device: Stepped Wedge Intervention Phase
- type
- EXPERIMENTAL
- label
- B - Crossover at month 3
- description
- Participants cross-over to Stepped Wedge Intervention Phase at month 3.
- interventionNames
- Device: Calibration Phase
- Device: Stepped Wedge Intervention Phase
- type
- EXPERIMENTAL
- label
- C - Crossover at month 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have leptomeningeal metastasis (LMM) diagnosed per clinical, imaging, and/or CSF/cytology criteria (cytology, flow cytometry, or circulating tumor DNA), arising from any solid or hematologic tumor primary. * Participants must be undergoing active anti-cancer therapy (systemic, intrathecal, and/or radiation) or active surveillance for LMM. * Age ≥18 years at the time of study enrollment. Because no safety or dosing data are available for wearable monitoring studies in children with LMM, participants under 18 years of age are excluded. * Karnofsky Performance Status (KPS) ≥50 at time of study enrollment \[See Appendix I\], to ensure feasibility of wearing the device for ≥10 hours/day. * Participants must have access to a compatible smartphone: * iPhone running iOS 16 or higher and willingness to wear Apple Watch ≥10 hours/day; OR * Android smartphone compatible with the study application and willingness to wear Samsung Galaxy Watch ≥10 hours/day. * Ability to provide informed consent (or a legally authorized representative \[LAR\] is available and willing to provide consent on the participant's behalf, if appropriate). Exclusion Criteria: * Anticipated life expectancy \<4 weeks at time of screening, per the treating physician. * Severe dermatologic or musculoskeletal conditions precluding smartwatch wear (e.g., significant skin conditions on the wrist or forearm where the device will be placed, including tattoos that may substantially interfere with optical sensor function). * Inability to adhere to study procedures after training, as assessed by the study team at enrollment. * No access to a compatible smartphone (participant or caregiver) to interface with the watch application for symptom documentation and data transfer. * Inability to give informed consent due to severe aphasia, severe cognitive impairment, or other language barrier, unless a legally authorized representative is available and willing to participate.
References
Publications (0)
Data not yet available