Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07704034
Status
Not Yet Recruiting

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Conditions

  • Leptomeningeal Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calibration Phase — DEVICE
    Apple Watch Series 6+ or Samsung Galaxy Watch 4+ worn 10+ hours/day for 4+ days/week for 6 months. Passive wearable data collection from in-house cross-platform app to find out patient-specific digital signal thresholds for neurological decline, symptom logging, daily sync reminders, and monthly EORTC-QLQ-C30 surveys.
  • Stepped Wedge Intervention Phase — DEVICE
    Apple Watch Series 6+ or Samsung Galaxy Watch 4+ worn 10+ hours/day for 4+ days/week for 5 months. Active monitoring with alerts using the data collected from the in-house cross-platform app and sent to study neuro-oncologist.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
May 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: A - Crossover at month 2
    Participants cross-over to Stepped Wedge Intervention Phase at month 2.
  • Experimental: B - Crossover at month 3
    Participants cross-over to Stepped Wedge Intervention Phase at month 3.
  • Experimental: C - Crossover at month 4
    Participants cross-over to Stepped Wedge Intervention Phase at month 4.

Primary Outcome Measure

Predicting Karnofsky Performance Scale (KPS) decline [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44106
Andrew Dhawan, MD, DPhil
[email protected]
216-444-5322

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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