Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
1 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Andrew Dhawan, MD, DPhil
- Numéro de téléphone: 216-444-5322
- E-mail: dhawana@ccf.org
Lieux d'étude
-
-
Ohio
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Cleveland, Ohio, États-Unis, 44106
- Cleveland Clinic, Case Comprehensive Cancer Center
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Contact:
- Andrew Dhawan, MD, DPhil
- Numéro de téléphone: 216-444-5322
- E-mail: dhawana@ccf.org
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Predicting Karnofsky Performance Scale (KPS) decline
Délai: 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
|
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Predicting neurological progression
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 months
|
number of participants enrolled within 9-12 months
|
12 months
|
|
Dropout rate
Délai: 12 months
|
Number of participants who do not complete study, assessed at study completion
|
12 months
|
|
Alert pathway feasibility
Délai: 5 months
|
Alert frequency per participant-month and proportion judged clinically relevant.
|
5 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of unplanned hospitalizations and ED visits per participant-month
Délai: 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
Délai: 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)
Délai: 12 months
|
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
|
12 months
|
|
Overall survival (OS)
Délai: 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
Délai: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Time from alert trigger to clinician-documented neurological progression
Délai: 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
Délai: 12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Participant symptoms
Délai: 12 months
|
Logged per type per participant per month.
Assessed at each treatment visit
|
12 months
|
|
Variance in accelerometry
Délai: 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)
Délai: 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
Délai: 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
Délai: 12 months
|
Collected via exit questionnaire at withdrawal or study completion
|
12 months
|
|
Participant device wear
Délai: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
|
12 months
|
|
Participant symptom logging
Délai: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
|
Participant app usage
Délai: 12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Andrew Dhawan, MD, DPhil, Cleveland Clinic, Case Comprehensive Cancer Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
15 mai 2027
Achèvement de l'étude (Estimé)
15 novembre 2027
Dates d'inscription aux études
Première soumission
30 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juillet 2026
Première publication (Réel)
15 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CASE5326
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .