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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leptomeningeal Metastasis
• Intervention / Treatment: Device: Calibration Phase; Device: Stepped Wedge Intervention Phase

Detailed Description

LMM is a condition where cancer has spread to the fluid and membranes surrounding the brain and spinal cord. It is a common complication of cancer and affects about 5-15% of all cancer patients. It causes rapid neurological decline and survival is usually around 6-12 months. LMM is treated with chemotherapy radiation, but this does not improve neurological function or quality of life. Many of the current assessments for LMM are not good detecting progression and symptoms are often missed.

There will be two parts to this study. Smartwatches will be used to continuously capture data such as gait stability, heart rate variability (HRV), step count, and sleep, which are affected by LMM. The first part of this study is to learn whether this can help detect early signs of neurological decline. The second part of this study will test whether sending an automatic alert to the participant's doctor when a change is detected can help reduce the amount of times the participants are admitted to the hospital unexpectedly.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Dhawan, MD, DPhil; Phone Number: 216-444-5322; Email: dhawana@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic, Case Comprehensive Cancer Center
      • Contact: Andrew Dhawan, MD, DPhil; Phone Number: 216-444-5322; Email: dhawana@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Crossover at month 2; Participants cross-over to Stepped Wedge Intervention Phase at month 2.	Device: Calibration Phase; 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.; Device: Stepped Wedge Intervention Phase; 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.
Experimental: B - Crossover at month 3; Participants cross-over to Stepped Wedge Intervention Phase at month 3.	Device: Calibration Phase; 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.; Device: Stepped Wedge Intervention Phase; 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.
Experimental: C - Crossover at month 4; Participants cross-over to Stepped Wedge Intervention Phase at month 4.	Device: Calibration Phase; 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.; Device: Stepped Wedge Intervention Phase; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unplanned hospitalizations and ED visits per participant-month	Evaluate the efficacy of alert pathway in reducing unplanned hospitalization and ED visits. EMR review throughout Phase 2 during active vs. silent periods.	5 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores	EORTC-QLQ-C30 is a 30 item validated questionnaire to determine the participant's quality of life. The questions are in a 4- point scale from 1 ("Not at all)" to 4 ("Very much"). A higher functional or global health score represents a higher quality of life, while a higher symptom score means a higher level of reported symptoms. Change in EORTC-QLQ-C30 will be measured from baseline at each time point.	6 months
Progression-free survival (PFS)	Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period	12 months
Overall survival (OS)	Time from enrollment to death; assessed throughout treatment period and via medical record review	12 months
Wearable data quantity across iOS and Android platforms	Assessed at each treatment visit per participant per month (mean, variance)	12 months
Time from alert trigger to clinician-documented neurological progression	Evaluate the efficacy of alert pathway in reducing unplanned hospitalization and ED visits. EMR review throughout Phase 2 during active vs. silent periods.	5 months
Wearable data quality across iOS and Android platforms	Assessed at each treatment visit per participant per month (mean, variance)	12 months
Participant symptoms	Logged per type per participant per month. Assessed at each treatment visit	12 months
Variance in accelerometry	This device is used to track changes in physical activity and sleep patterns. Assessed at study completion	12 months
Variance in heart rate variability (HRV)	This device assess HRV, which is where the amount of time between heartbeats fluctuate slightly. The participant's heart data will be collected and used to see if there any changes from the participant's month 1 mean. Assessed at study completion	12 months
Variance in gait metrics	This device assesses the speed, step length and asymmetry to see if changes these can predict any clinical events by days to weeks.	12 months
Reasons for dropout	Collected via exit questionnaire at withdrawal or study completion	12 months
Participant device wear	Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)	12 months
Participant symptom logging	Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).	12 months
Participant app usage	Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).	12 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Brain and Nervous System
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations; Meningeal Carcinomatosis
• Other Study ID Numbers: CASE5326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be shared in aggregate statistics. There is no universal standard for "raw" wearable data, making IPD sharing less useful without providing the entire technical infrastructure used by the original team. This trial is expected to generate massive datasets (gigabytes per participant). Curating, de-identifying, and hosting this volume of IPD for public access requires significant long-term funding and technical oversight that may be beyond the scope of this Investigator-Initiated Trial (IIT).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No