Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
2026年9月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Andrew Dhawan, MD, DPhil
- 電話番号：216-444-5322
- メール：dhawana@ccf.org
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44106
- Cleveland Clinic, Case Comprehensive Cancer Center
-
コンタクト：
- Andrew Dhawan, MD, DPhil
- 電話番号：216-444-5322
- メール：dhawana@ccf.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Predicting Karnofsky Performance Scale (KPS) decline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 months
|
number of participants enrolled within 9-12 months
|
12 months
|
|
Dropout rate
時間枠：12 months
|
Number of participants who do not complete study, assessed at study completion
|
12 months
|
|
Alert pathway feasibility
時間枠：5 months
|
Alert frequency per participant-month and proportion judged clinically relevant.
|
5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of unplanned hospitalizations and ED visits per participant-month
時間枠：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
時間枠：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)
時間枠：12 months
|
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
|
12 months
|
|
Overall survival (OS)
時間枠：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
時間枠：12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Time from alert trigger to clinician-documented neurological progression
時間枠：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
時間枠：12 months
|
Assessed at each treatment visit per participant per month (mean, variance)
|
12 months
|
|
Participant symptoms
時間枠：12 months
|
Logged per type per participant per month.
Assessed at each treatment visit
|
12 months
|
|
Variance in accelerometry
時間枠：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)
時間枠：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
時間枠：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
時間枠：12 months
|
Collected via exit questionnaire at withdrawal or study completion
|
12 months
|
|
Participant device wear
時間枠：12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
|
12 months
|
|
Participant symptom logging
時間枠：12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
|
Participant app usage
時間枠：12 months
|
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
|
12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Andrew Dhawan, MD, DPhil、Cleveland Clinic, Case Comprehensive Cancer Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2027年5月15日
研究の完了 (推定)
2027年11月15日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CASE5326
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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).
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。