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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Predicting Karnofsky Performance Scale (KPS) decline [Time frame: 6 months]
• Predicting neurological progression [Time frame: 6 months]
• Days in hospital per participant-month during silent monitoring periods [Time frame: 5 months]
• Days in hospital per participant-month during active alerting periods [Time frame: 5 months]
• Participant completion [Time frame: 5 months]
• Recruitment rate [Time frame: 12 months]
• Dropout rate [Time frame: 12 months]
• Alert pathway feasibility [Time frame: 5 months]

Secondary outcome measures (12)

• Number of unplanned hospitalizations and ED visits per participant-month [Time frame: 5 months]
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores [Time frame: 6 months]
• Progression-free survival (PFS) [Time frame: 12 months]
• Overall survival (OS) [Time frame: 12 months]
• Wearable data quantity across iOS and Android platforms [Time frame: 12 months]
• Time from alert trigger to clinician-documented neurological progression [Time frame: 5 months]
• Wearable data quality across iOS and Android platforms [Time frame: 12 months]
• Participant symptoms [Time frame: 12 months]
• Variance in accelerometry [Time frame: 12 months]
• Variance in heart rate variability (HRV) [Time frame: 12 months]
• Variance in gait metrics [Time frame: 12 months]
• Reasons for dropout [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT07704034 · CASE5326

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗