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.
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.
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.
Parallel
Calibration Phase
DeviceApple 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
DeviceApple 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.
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.
Predicting neurological progression
Sensitivity, specificity, PPV, and lead time of participant-specific thresholds. Assessed from calibration phase data.
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.
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.
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.
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.
Progression-free survival (PFS)
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
Overall survival (OS)
Time from enrollment to death; assessed throughout treatment period and via medical record review
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