Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
1 september 2026 bijgewerkt door: Case Comprehensive Cancer Center
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Andrew Dhawan, MD, DPhil
- Telefoonnummer: 216-444-5322
- E-mail: dhawana@ccf.org
Studie Locaties
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-
Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- Cleveland Clinic, Case Comprehensive Cancer Center
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Contact:
- Andrew Dhawan, MD, DPhil
- Telefoonnummer: 216-444-5322
- E-mail: dhawana@ccf.org
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: A - Crossover at month 2
Participants cross-over to Stepped Wedge Intervention Phase at month 2.
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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.
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.
|
|
Experimenteel: B - Crossover at month 3
Participants cross-over to Stepped Wedge Intervention Phase at month 3.
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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.
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.
|
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Experimenteel: C - Crossover at month 4
Participants cross-over to Stepped Wedge Intervention Phase at month 4.
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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.
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Predicting Karnofsky Performance Scale (KPS) decline
Tijdsspanne: 6 months
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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.
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6 months
|
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Predicting neurological progression
Tijdsspanne: 6 months
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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
Tijdsspanne: 5 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.
|
5 months
|
|
Days in hospital per participant-month during active alerting periods
Tijdsspanne: 5 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.
|
5 months
|
|
Participant completion
Tijdsspanne: 5 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
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5 months
|
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Recruitment rate
Tijdsspanne: 12 months
|
number of participants enrolled within 9-12 months
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12 months
|
|
Dropout rate
Tijdsspanne: 12 months
|
Number of participants who do not complete study, assessed at study completion
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12 months
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Alert pathway feasibility
Tijdsspanne: 5 months
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Alert frequency per participant-month and proportion judged clinically relevant.
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5 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of unplanned hospitalizations and ED visits per participant-month
Tijdsspanne: 5 months
|
Evaluate the efficacy of alert pathway in reducing unplanned hospitalization and ED visits.
EMR review throughout Phase 2 during active vs. silent periods.
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5 months
|
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European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores
Tijdsspanne: 6 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.
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6 months
|
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Progression-free survival (PFS)
Tijdsspanne: 12 months
|
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
|
12 months
|
|
Overall survival (OS)
Tijdsspanne: 12 months
|
Time from enrollment to death; assessed throughout treatment period and via medical record review
|
12 months
|
|
Wearable data quantity across iOS and Android platforms
Tijdsspanne: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
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Time from alert trigger to clinician-documented neurological progression
Tijdsspanne: 5 months
|
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
Tijdsspanne: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
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Participant symptoms
Tijdsspanne: 12 months
|
Logged per type per participant per month.
Assessed at each treatment visit
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12 months
|
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Variance in accelerometry
Tijdsspanne: 12 months
|
This device is used to track changes in physical activity and sleep patterns.
Assessed at study completion
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12 months
|
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Variance in heart rate variability (HRV)
Tijdsspanne: 12 months
|
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
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12 months
|
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Variance in gait metrics
Tijdsspanne: 12 months
|
This device assesses the speed, step length and asymmetry to see if changes these can predict any clinical events by days to weeks.
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12 months
|
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Reasons for dropout
Tijdsspanne: 12 months
|
Collected via exit questionnaire at withdrawal or study completion
|
12 months
|
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Participant device wear
Tijdsspanne: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
|
12 months
|
|
Participant symptom logging
Tijdsspanne: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
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Participant app usage
Tijdsspanne: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 november 2026
Primaire voltooiing (Geschat)
15 mei 2027
Studie voltooiing (Geschat)
15 november 2027
Studieregistratiedata
Eerst ingediend
30 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juli 2026
Eerst geplaatst (Werkelijk)
15 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CASE5326
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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).
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .