Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
1. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Andrew Dhawan, MD, DPhil
- Telefonnummer: 216-444-5322
- E-post: dhawana@ccf.org
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Cleveland Clinic, Case Comprehensive Cancer Center
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Ta kontakt med:
- Andrew Dhawan, MD, DPhil
- Telefonnummer: 216-444-5322
- E-post: dhawana@ccf.org
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
|
Eksperimentell: 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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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Predicting Karnofsky Performance Scale (KPS) decline
Tidsramme: 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
Tidsramme: 6 months
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Sensitivity, specificity, PPV, and lead time of participant-specific thresholds.
Assessed from calibration phase data.
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6 months
|
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Days in hospital per participant-month during silent monitoring periods
Tidsramme: 5 months
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Taken from EMR by staff blinded to alert status.
Defined as incidence rate ratios (IRRs) with 95% CIs using mixed-effects negative binomial regression.
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5 months
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Days in hospital per participant-month during active alerting periods
Tidsramme: 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.
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5 months
|
|
Participant completion
Tidsramme: 5 months
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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
Tidsramme: 12 months
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number of participants enrolled within 9-12 months
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12 months
|
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Dropout rate
Tidsramme: 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
Tidsramme: 5 months
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Alert frequency per participant-month and proportion judged clinically relevant.
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5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of unplanned hospitalizations and ED visits per participant-month
Tidsramme: 5 months
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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
Tidsramme: 6 months
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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)
Tidsramme: 12 months
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Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
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12 months
|
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Overall survival (OS)
Tidsramme: 12 months
|
Time from enrollment to death; assessed throughout treatment period and via medical record review
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12 months
|
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Wearable data quantity across iOS and Android platforms
Tidsramme: 12 months
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Assessed at each treatment visit per participant per month (mean, variance)
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12 months
|
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Time from alert trigger to clinician-documented neurological progression
Tidsramme: 5 months
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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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Wearable data quality across iOS and Android platforms
Tidsramme: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Participant symptoms
Tidsramme: 12 months
|
Logged per type per participant per month.
Assessed at each treatment visit
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12 months
|
|
Variance in accelerometry
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
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Collected via exit questionnaire at withdrawal or study completion
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12 months
|
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Participant device wear
Tidsramme: 12 months
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Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
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12 months
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Participant symptom logging
Tidsramme: 12 months
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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
Tidsramme: 12 months
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Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. november 2026
Primær fullføring (Antatt)
15. mai 2027
Studiet fullført (Antatt)
15. november 2027
Datoer for studieregistrering
Først innsendt
30. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juli 2026
Først lagt ut (Faktiske)
15. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE5326
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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).
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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