Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
1 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
48
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Andrew Dhawan, MD, DPhil
- Numero di telefono: 216-444-5322
- Email: dhawana@ccf.org
Luoghi di studio
-
-
Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Cleveland Clinic, Case Comprehensive Cancer Center
-
Contatto:
- Andrew Dhawan, MD, DPhil
- Numero di telefono: 216-444-5322
- Email: dhawana@ccf.org
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: A - Crossover at month 2
Participants cross-over to Stepped Wedge Intervention Phase at month 2.
|
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.
|
|
Sperimentale: B - Crossover at month 3
Participants cross-over to Stepped Wedge Intervention Phase at month 3.
|
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.
|
|
Sperimentale: C - Crossover at month 4
Participants cross-over to Stepped Wedge Intervention Phase at month 4.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Predicting Karnofsky Performance Scale (KPS) decline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
|
number of participants enrolled within 9-12 months
|
12 months
|
|
Dropout rate
Lasso di tempo: 12 months
|
Number of participants who do not complete study, assessed at study completion
|
12 months
|
|
Alert pathway feasibility
Lasso di tempo: 5 months
|
Alert frequency per participant-month and proportion judged clinically relevant.
|
5 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of unplanned hospitalizations and ED visits per participant-month
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 12 months
|
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
|
12 months
|
|
Overall survival (OS)
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Time from alert trigger to clinician-documented neurological progression
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Participant symptoms
Lasso di tempo: 12 months
|
Logged per type per participant per month.
Assessed at each treatment visit
|
12 months
|
|
Variance in accelerometry
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Collected via exit questionnaire at withdrawal or study completion
|
12 months
|
|
Participant device wear
Lasso di tempo: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
|
12 months
|
|
Participant symptom logging
Lasso di tempo: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
|
Participant app usage
Lasso di tempo: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 novembre 2026
Completamento primario (Stimato)
15 maggio 2027
Completamento dello studio (Stimato)
15 novembre 2027
Date di iscrizione allo studio
Primo inviato
30 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CASE5326
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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).
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .