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AI-Assisted Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction

6. november 2026 oppdatert av: Hospital Universitario 12 de Octubre

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Spania
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
    • Madrid
      • Majadahonda, Madrid, Spania, 28041
        • Hospital Universitario Puerta del Hierro

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Enhet: 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. Patient responses generate predefined alerts that can be reviewed by healthcare professionals to support clinical management.
Annen: Standard Care

Routine clinical management and follow-up
Annen: Standard of Care

Participants will receive routine clinical management and follow-up according to local standard-of-care practices.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MBO-related hospital admissions
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Within 90 days after randomization

Ratio of days alive and out of hospital to days spent in hospital
Within 90 days after randomization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Universitario 12 de Octubre

Etterforskere

  • Hovedetterforsker: Ainhoa Madariaga Urrutia, Hospital Universitario 12 de Octubre
  • Hovedetterforsker: Constanza Maximiano, Dra, Puerta de Hierro University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. februar 2029

Studiet fullført (Antatt)

1. november 2029

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SMART-MBO

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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