Wearable-Triggered Digital Safety Net for Real-Time Monitoring and Intervention in Leptomeningeal Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
A - Crossover at month 2
Participants cross-over to Stepped Wedge Intervention Phase at month 2.
干预措施: Stepped Wedge Intervention Phase (Device)
C - Crossover at month 4
Participants cross-over to Stepped Wedge Intervention Phase at month 4.
干预措施: Calibration Phase (Device)
C - Crossover at month 4
Participants cross-over to Stepped Wedge Intervention Phase at month 4.
干预措施: Stepped Wedge Intervention Phase (Device)
A - Crossover at month 2
Participants cross-over to Stepped Wedge Intervention Phase at month 2.
干预措施: Calibration Phase (Device)
B - Crossover at month 3
Participants cross-over to Stepped Wedge Intervention Phase at month 3.
干预措施: Calibration Phase (Device)
B - Crossover at month 3
Participants cross-over to Stepped Wedge Intervention Phase at month 3.
干预措施: Stepped Wedge Intervention Phase (Device)
结局指标
主要结局
Recruitment rate
时间窗: 12 months
number of participants enrolled within 9-12 months
Predicting Karnofsky Performance Scale (KPS) decline
时间窗: 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.
Predicting neurological progression
时间窗: 6 months
Sensitivity, specificity, PPV, and lead time of participant-specific thresholds. Assessed from calibration phase data.
Days in hospital per participant-month during silent monitoring periods
时间窗: 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.
Days in hospital per participant-month during active alerting periods
时间窗: 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.
Participant completion
时间窗: 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
Dropout rate
时间窗: 12 months
Number of participants who do not complete study, assessed at study completion
Alert pathway feasibility
时间窗: 5 months
Alert frequency per participant-month and proportion judged clinically relevant.
次要结局
- Number of unplanned hospitalizations and ED visits per participant-month(5 months)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores(6 months)
- Progression-free survival (PFS)(12 months)
- Overall survival (OS)(12 months)
- Wearable data quantity across iOS and Android platforms(12 months)
- Time from alert trigger to clinician-documented neurological progression(5 months)
- Wearable data quality across iOS and Android platforms(12 months)
- Participant symptoms(12 months)
- Variance in accelerometry(12 months)
- Variance in heart rate variability (HRV)(12 months)
- Variance in gait metrics(12 months)
- Reasons for dropout(12 months)
- Participant device wear(12 months)
- Participant symptom logging(12 months)
- Participant app usage(12 months)