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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Predicting Karnofsky Performance Scale (KPS) decline [Срок оценки: 6 months]
• Predicting neurological progression [Срок оценки: 6 months]
• Days in hospital per participant-month during silent monitoring periods [Срок оценки: 5 months]
• Days in hospital per participant-month during active alerting periods [Срок оценки: 5 months]
• Participant completion [Срок оценки: 5 months]
• Recruitment rate [Срок оценки: 12 months]
• Dropout rate [Срок оценки: 12 months]
• Alert pathway feasibility [Срок оценки: 5 months]

Вторичные конечные точки (12)

• Number of unplanned hospitalizations and ED visits per participant-month [Срок оценки: 5 months]
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores [Срок оценки: 6 months]
• Progression-free survival (PFS) [Срок оценки: 12 months]
• Overall survival (OS) [Срок оценки: 12 months]
• Wearable data quantity across iOS and Android platforms [Срок оценки: 12 months]
• Time from alert trigger to clinician-documented neurological progression [Срок оценки: 5 months]
• Wearable data quality across iOS and Android platforms [Срок оценки: 12 months]
• Participant symptoms [Срок оценки: 12 months]
• Variance in accelerometry [Срок оценки: 12 months]
• Variance in heart rate variability (HRV) [Срок оценки: 12 months]
• Variance in gait metrics [Срок оценки: 12 months]
• Reasons for dropout [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Идентификаторы

NCT: NCT07704034 · CASE5326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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