Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
tiistai 1. syyskuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
48
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Andrew Dhawan, MD, DPhil
- Puhelinnumero: 216-444-5322
- Sähköposti: dhawana@ccf.org
Opiskelupaikat
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44106
- Cleveland Clinic, Case Comprehensive Cancer Center
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Ottaa yhteyttä:
- Andrew Dhawan, MD, DPhil
- Puhelinnumero: 216-444-5322
- Sähköposti: dhawana@ccf.org
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Laitteen toteutettavuus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
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Kokeellinen: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Predicting Karnofsky Performance Scale (KPS) decline
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Participant completion
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 12 months
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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
Aikaikkuna: 5 months
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Alert frequency per participant-month and proportion judged clinically relevant.
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5 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of unplanned hospitalizations and ED visits per participant-month
Aikaikkuna: 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
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 12 months
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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
Aikaikkuna: 12 months
|
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
Aikaikkuna: 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
Aikaikkuna: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
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12 months
|
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Participant symptoms
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 12 months
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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 app usage
Aikaikkuna: 12 months
|
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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Sunnuntai 1. marraskuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Lauantai 15. toukokuuta 2027
Opintojen valmistuminen (Arvioitu)
Maanantai 15. marraskuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 30. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 9. heinäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 15. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 3. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 1. syyskuuta 2026
Viimeksi vahvistettu
Tiistai 1. syyskuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CASE5326
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
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).
Lääke- ja laitetiedot, tutkimusasiakirjat
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Ei
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Ei
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