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

NCT07704034 | Not Yet Recruiting

• 1 other identifier: CASE5326
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leptomeningeal Metastasis

Keywords

Brain and Nervous System

Outcome Measures

Primary Outcomes (8)

• Predicting Karnofsky Performance Scale (KPS) decline

  Karnofsky Performance scale of 100-0. Sensitivity, specificity, Positive Predictive Value (PPV), and lead time of participant-specific thresholds. Assessed from calibration phase data if there is a greater than10-point KPS decline.

  6 months

• Predicting neurological progression

  Sensitivity, specificity, PPV, and lead time of participant-specific thresholds. Assessed from calibration phase data.

  6 months

• Days in hospital per participant-month during silent monitoring periods

  Taken from EMR by staff blinded to alert status. Defined as incidence rate ratios (IRRs) with 95% CIs using mixed-effects negative binomial regression.

  5 months

• Days in hospital per participant-month during active alerting periods

  Taken from EMR by staff blinded to alert status. Defined as incidence rate ratios (IRRs) with 95% CIs using mixed-effects negative binomial regression.

  5 months

• Participant completion

  80% or more of participants completing 3 months or more of active monitoring with median wear of 10 or more hours on 4 or more days/week

  5 months

• Recruitment rate

  number of participants enrolled within 9-12 months

  12 months

• Dropout rate

  Number of participants who do not complete study, assessed at study completion

  12 months

• Alert pathway feasibility

  Alert frequency per participant-month and proportion judged clinically relevant.

  5 months

Secondary Outcomes (15)

• Number of unplanned hospitalizations and ED visits per participant-month

  5 months

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores

  6 months

• Progression-free survival (PFS)

  12 months

• Overall survival (OS)

  12 months

• Wearable data quantity across iOS and Android platforms

  12 months

Study Arms (3)

A - Crossover at month 2

EXPERIMENTAL

Participants cross-over to Stepped Wedge Intervention Phase at month 2.

Device: Calibration Phase; Device: Stepped Wedge Intervention Phase

B - Crossover at month 3

EXPERIMENTAL

Participants cross-over to Stepped Wedge Intervention Phase at month 3.

Device: Calibration Phase; Device: Stepped Wedge Intervention Phase

C - Crossover at month 4

EXPERIMENTAL

Participants cross-over to Stepped Wedge Intervention Phase at month 4.

Device: Calibration Phase; Device: Stepped Wedge Intervention Phase

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.

A - Crossover at month 2; B - Crossover at month 3; C - Crossover at month 4

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.

A - Crossover at month 2; B - Crossover at month 3; C - Crossover at month 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Dhawan, MD, DPhil

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Dhawan, MD, DPhil

CONTACT

216-444-5322; dhawana@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)