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

9. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Andrew Dhawan, MD, DPhil
  • Telefonní číslo: 216-444-5322
  • E-mail: dhawana@ccf.org

Studijní místa

  • Spojené státy
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44106
        • Cleveland Clinic, Case Comprehensive Cancer Center
        • Kontakt:
          • Andrew Dhawan, MD, DPhil
          • Telefonní číslo: 216-444-5322
          • E-mail: dhawana@ccf.org

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Proveditelnost zařízení
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: A - Crossover at month 2
Participants cross-over to Stepped Wedge Intervention Phase at month 2.
Přístroj: 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.
Přístroj: 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.
Experimentální: B - Crossover at month 3
Participants cross-over to Stepped Wedge Intervention Phase at month 3.
Přístroj: 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.
Přístroj: 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.
Experimentální: C - Crossover at month 4
Participants cross-over to Stepped Wedge Intervention Phase at month 4.
Přístroj: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Predicting Karnofsky Performance Scale (KPS) decline
Časové okno: 6 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.
6 months
Predicting neurological progression
Časové okno: 6 months
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
5 months
Recruitment rate
Časové okno: 12 months
number of participants enrolled within 9-12 months
12 months
Dropout rate
Časové okno: 12 months
Number of participants who do not complete study, assessed at study completion
12 months
Alert pathway feasibility
Časové okno: 5 months
Alert frequency per participant-month and proportion judged clinically relevant.
5 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of unplanned hospitalizations and ED visits per participant-month
Časové okno: 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
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores
Časové okno: 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.
6 months
Progression-free survival (PFS)
Časové okno: 12 months
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
12 months
Overall survival (OS)
Časové okno: 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
Časové okno: 12 months
Assessed at each treatment visit per participant per month (mean, variance)
12 months
Time from alert trigger to clinician-documented neurological progression
Časové okno: 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
Časové okno: 12 months
Assessed at each treatment visit per participant per month (mean, variance)
12 months
Participant symptoms
Časové okno: 12 months
Logged per type per participant per month. Assessed at each treatment visit
12 months
Variance in accelerometry
Časové okno: 12 months
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)
Časové okno: 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
12 months
Variance in gait metrics
Časové okno: 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.
12 months
Reasons for dropout
Časové okno: 12 months
Collected via exit questionnaire at withdrawal or study completion
12 months
Participant device wear
Časové okno: 12 months
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
12 months
Participant symptom logging
Časové okno: 12 months
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
12 months
Participant app usage
Časové okno: 12 months
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Case Comprehensive Cancer Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

15. května 2027

Dokončení studie (Odhadovaný)

15. listopadu 2027

Termíny zápisu do studia

První předloženo

30. června 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

15. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CASE5326

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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).

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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