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Smartwatch Monitoring for Leptomeningeal Metastasis

This study is for people diagnosed with leptomeningeal metastasis (LMM), a condition where cancer has spread to the fluid and membranes around the brain and spinal cord. It aims to see if a consumer smartwatch (Apple Watch Series 6+ or Samsung Galaxy Watch 4+) can continuously monitor your health and detect early signs of neurological decline. The study also wants to find out if sending an automatic alert to your doctor when changes are detected can help reduce hospital stays. You can join if you are 18 or older, have LMM from any solid or blood cancer, and are currently receiving cancer treatment or active monitoring for LMM. Success will be measured by how well the smartwatch predicts a decline in your daily function and neurological progression, and by the number of days you spend in the hospital.

Study design
This is an interventional study planning to enroll 48 participants. It involves two phases: a calibration phase followed by a stepped wedge intervention phase.
What's involved
You would wear an Apple Watch Series 6+ or Samsung Galaxy Watch 4+ for at least 10 hours a day, 4 days a week, for a total of 11 months. This includes passive data collection and active monitoring with alerts.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 5 and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07704034

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

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
Case Comprehensive Cancer Center
~48 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Calibration PhaseStepped Wedge Intervention Phase

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Predicting Karnofsky Performance Scale (KPS) decline
Measured over 6 months
+7 more outcomes measured

Conditions

Leptomeningeal Metastasis

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Metastatic Malignant Neoplasm in the Leptomeninges

NCT07704034

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic, Case Comprehensive Cancer Center

    Cleveland, Ohiostudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew Dhawan, MD, DPhil · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

Who to contact

Andrew Dhawan, MD, DPhil
[email protected]
216-444-5322
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Predicting Karnofsky Performance Scale (KPS) decline6 months

    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 progression6 months

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

  • Days in hospital per participant-month during silent monitoring periods5 months

    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 periods5 months

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

  • Participant completion5 months

    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

  • Recruitment rate12 months

    number of participants enrolled within 9-12 months

  • Dropout rate12 months

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

  • Alert pathway feasibility5 months

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