AI-Assisted Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction
A Pragmatic Phase II Randomized Clinical Trial of Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction (MBO)
The goal of this clinical trial is to learn whether artificial intelligence (AI)-assisted remote symptom monitoring can reduce hospital admissions related to malignant bowel obstruction (MBO) in patients with advanced cancer who have MBO or are at risk of developing MBO.
The main questions it aims to answer are:
- Does AI-assisted remote symptom monitoring reduce the proportion of patients who experience at least one hospital admission due to MBO within 90 days?
- Does AI-assisted remote symptom monitoring improve patient-reported outcomes, quality of life, healthcare resource utilization, and survival outcomes compared with standard care? Researchers will compare AI-assisted remote symptom monitoring plus standard care with standard care alone to determine whether remote monitoring can reduce MBO-related hospital admissions and improve patient outcomes.
Participants will receive study-specific assessments and follow-up for at least 90 days. Participants in the monitoring group will receive regular automated symptom-monitoring calls, and optional stool samples may be collected for microbiome research
調査の概要
詳細な説明
This is a prospective, pragmatic, randomized phase II clinical trial evaluating AI-assisted remote symptom monitoring in patients with advanced cancer who have MBO managed in the outpatient setting or are at risk of developing MBO. All participants will receive standard clinical management according to local standard of care, as well as educational materials regarding MBO, symptoms requiring medical attention, symptom management recommendations, and dietary advice.
Eligible participants will be identified using the Princess Margaret Malignant Bowel Obstruction (PMMBO) risk stratification system. Patients classified as yellow (at risk of MBO) or orange (outpatient MBO) will be eligible for the study. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to either the AI-assisted remote monitoring arm or the standard-of-care arm. Randomization will be stratified by previous MBO-related hospital admission (yes/no), baseline PMMBO risk category (yellow/orange), and study site.
This study consists of two study arms:
- Standard-of-Care Arm: Participants randomized to this arm will receive routine clinical follow-up and management according to local institutional practice.
- AI-Assisted Remote Monitoring Arm: Participants randomized to this arm will receive standard care plus remote symptom monitoring through an AI-based conversational platform. The platform will perform structured symptom assessments through automated telephone calls using a predefined questionnaire focused on MBO-related symptoms. Monitoring will be performed at least once per week and may be increased according to patient symptoms and clinical needs. Participant responses will be assessed in real time and predefined alerts will be displayed through a nursing dashboard, allowing healthcare professionals to review symptoms and initiate clinical interventions when considered necessary.
A total of 140 participants will be enrolled and randomized, with 70 participants assigned to each study arm. Participants will undergo baseline and follow-up assessments according to the study schedule and will be followed for at least 90 days after randomization. Monitoring in the intervention arm may continue beyond Day 90, if clinically indicated, for a maximum duration of 12 months.
The estimated recruitment period is 24 months
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ainhoa Madariaga Urrutia
- 電話番号：+34645719358
- メール：ainhoa.madariaga@salud.madrid.org
研究連絡先のバックアップ
- 名前：Daniel Fernández Villa
- 電話番号：454637 +34917792637
- メール：danielfvilla.imas12@h12o.es
研究場所
-
-
-
Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
-
-
Madrid
-
Majadahonda、Madrid、スペイン、28041
- Hospital Universitario Puerta del Hierro
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically and/or cytologically confirmed diagnosis of advanced malignancy.
- Considered to be at risk of developing MBO, defined as PMMBO yellow classification, or presenting a clinical diagnosis of MBO, characterized by clinical evidence of bowel obstruction (based on medical history, physical examination, and/or radiological assessment) distal to the ligament of Treitz, and deemed suitable for ambulatory management.
- Receiving active oncologic therapy at the time of enrollment.
- Able to understand and communicate effectively in Spanish.
Exclusion Criteria:
- Inability to understand and communicate in Spanish.
研究計画
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：支持療法
- 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：AI- Assisted Remote Monitoring + Standard Care
AI-Assisted Remote Symptom Monitoring An artificial intelligence-based conversational platform used to remotely assess symptoms associated with malignant bowel obstruction through automated telephone calls |
An artificial intelligence-based conversational platform used to remotely assess symptoms associated with malignant bowel obstruction through automated telephone calls. Patient responses generate predefined alerts that can be reviewed by healthcare professionals to support clinical management. |
|
他の：Standard Care
Routine clinical management and follow-up |
Participants will receive routine clinical management and follow-up according to local standard-of-care practices. |
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 |
|---|---|---|
|
MBO-related hospital admissions
時間枠：Within 90 days after randomization
|
Proportion of participants experiencing at least one hospital admission due to malignant bowel obstruction (MBO) |
Within 90 days after randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：Up to 12 months after randomization
|
Overall survival measured from active MBO development to death from any cause |
Up to 12 months after randomization
|
|
Change in quality of life
時間枠：Baseline and Day 90 (±14 days)
|
Change from baseline in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire and gastrointestinal symptom subscale. The EORTC QLQ-C30 is a validated questionnaire used to assess health-related quality of life in patients with cancer. Scores range from 0 to 100. Higher scores on functional and global health status scales indicate better functioning and quality of life, whereas higher scores on symptom scales indicate greater symptom burden. The gastrointestinal symptom subscale evaluates the severity and frequency of gastrointestinal symptoms associated with malignant bowel obstruction. Higher scores indicate greater symptom burden and worsening gastrointestinal symptoms. |
Baseline and Day 90 (±14 days)
|
|
Emergency department assessments due to MBO
時間枠：Within 90 days after randomization
|
Number of emergency department assessments related to MBO |
Within 90 days after randomization
|
|
Time to first MBO-related hospital admission
時間枠：Within 90 days after randomization
|
Time from randomization to first hospital admission due to MBO |
Within 90 days after randomization
|
|
Length of hospital stay due to MBO
時間枠：Within 90 days after randomization
|
Duration of hospital stays related to MBO in days |
Within 90 days after randomization
|
|
Days alive and out of hospital
時間枠：Within 90 days after randomization
|
Ratio of days alive and out of hospital to days spent in hospital |
Within 90 days after randomization
|
協力者と研究者
捜査官
- 主任研究者：Ainhoa Madariaga Urrutia、Hospital Universitario 12 de Octubre
- 主任研究者：Constanza Maximiano, Dra、Puerta de Hierro University Hospital
出版物と役立つリンク
一般刊行物
- Madariaga A, Tuñon I, Sánchez-Castro S, et al: Automated conversational artificial intelligence (AI) for outpatient malignant bowel obstruction (MBO) symptom monitoring. Journal of Clinical Oncology 43:1547-1547, 2025
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SMART-MBO
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?
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
米国FDA規制機器製品の研究
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。