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
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ainhoa Madariaga Urrutia
- 전화번호: +34645719358
- 이메일: ainhoa.madariaga@salud.madrid.org
연구 연락처 백업
- 이름: Daniel Fernández Villa
- 전화번호: 454637 +34917792637
- 이메일: danielfvilla.imas12@h12o.es
연구 장소
-
-
-
Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
-
-
Madrid
-
Majadahonda, Madrid, 스페인, 28041
- Hospital Universitario Puerta del Hierro
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
다른: Standard Care
Routine clinical management and follow-up |
Participants will receive routine clinical management and follow-up according to local standard-of-care practices. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MBO-related hospital admissions
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Within 90 days after randomization
|
Ratio of days alive and out of hospital to days spent in hospital |
Within 90 days after randomization
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ainhoa Madariaga Urrutia, Hospital Universitario 12 de Octubre
- 수석 연구원: Constanza Maximiano, Dra, Puerta de Hierro University Hospital
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SMART-MBO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .