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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Crossover at month 2 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 2. |
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| B - Crossover at month 3 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 3. |
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| C - Crossover at month 4 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Dhawan, MD, DPhil | Contact | 216-444-5322 | dhawana@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Dhawan, MD, DPhil | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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).
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| ID | Term |
|---|---|
| D055756 | Meningeal Carcinomatosis |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 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. |
|
| 12 months |
| Alert pathway feasibility | Alert frequency per participant-month and proportion judged clinically relevant. | 5 months |
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 |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |