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AI-assisted Integrated Care to Promote Colonoscopy Uptake

NCT07261059 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-03

No results posted yet for this study

Summary

Colorectal cancer (CRC) ranks the second most common cancer and the fourth leading cause of cancer-related deaths in China. Early screening of CRC has been proven to reduce the incidence and mortality, with colonoscopy as the gold standard for CRC screening. This trial aims to evaluate the effectiveness of artificial intelligence-assistant integrated care for improving uptake rate of colonoscopy among high-risk individuals aged 40 to 64 in China. It's a two-arm, parallel cluster randomized controlled trial. The main question it aims to answer is whether the AI-assisted integrated care influence participants' screening-related knowledge, health beliefs, behavioral intention, and uptake of colonoscopy.

Participants will:

1. Be recruited and allocated into one of two groups according to the assigned clusters. Participants in one group will be invited to receive usual specialty care. In addition to usual specialty care, participants in the other group will receive AI-assisted integrated care provided by specialist and general practitioners collaboratively.
2. Complete a questionnaire survey on their knowledge, health beliefs, behavioral intention on CRC screening.
3. Have their colonoscopy status checked at the middle and end of trial.

Conditions

  • Colorectal Neoplasms
  • Colonoscopy

Interventions

BEHAVIORAL

AI-assisted integrated care

A colorectal cancer screening chatbot delivered via WeChat or a web browser, designed to provide information and health education about the colonoscopy, including essential knowledge, screening rationale, methods, procedural details, and local screening policies,. The chatbot is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the China colorectal cancer screening guidelines to ensure accuracy. The knowledge base is validated by colorectal cancer specialists. The chatbot engages users in interactive, conversational dialogue to answer questions and address concerns regarding colorectal cancer and colonoscopy. In addition to a colonoscopy recommendation from a county specialist at on-site, general practitioners will also join to provide recommendation and brief reminder of colonoscopy within the follow-up period.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Shandong University

    collaborator OTHER

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhiyuan Hou, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-09-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261059 on ClinicalTrials.gov