AI-assisted Integrated Care to Promote Colonoscopy Uptake

NCT07261059 | Not Yet Recruiting DMC

• 1 other identifier: Fudan-CRC chatbot
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.Complete a questionnaire survey on their knowledge, health beliefs, behavioral intention on CRC screening.
3. 3.Have their colonoscopy status checked at the middle and end of trial.

Conditions

Colorectal Neoplasms; Colonoscopy

Keywords

colorectal cancer; colonoscopy; artificial intelligence; integrated care; trial

Outcome Measures

Primary Outcomes (2)

• Uptake of colonoscopy

  Whether participants receive colonoscopy for colorectal cancer screening.Data will be collected from information system of hospitals.

  Three and six months after recruitment

• Time to completion of colonoscopy

  The interval from intervention initiation to the colonoscopy procedure. Data will be collected from information systems of hospitals.

  Six months after recruitment

Secondary Outcomes (6)

• CRC screening literacy

  One month after recruitment

• CRC screening belief

  One month after recruitment

• Colonoscopy behavioral intention

  One month after recruitment

• User engagement level with chatbot

  Six months after recruitment

• Usability of AI-assisted integrated care intervention

  Six months after recruitment

Study Arms (2)

AICC intervention group

EXPERIMENTAL

Participants in the intervention group will receive AICC. This includes a colonoscopy recommendation from a county specialist for both participants and their families, followed by an introduction to and guided registration for a CRC education chatbot with an initial 5-minute tutorial. Subsequently, general practitioners will conduct three monthly face-by-face follow-ups, each comprising a brief reminder of colonoscopy and a guided usage of CRC education chatbot.

Behavioral: AI-assisted integrated care

Control group

NO INTERVENTION

Participants in this group will receive usual specialty care, only a colonoscopy recommendation from a county specialists. For ethical considerations, participants in this arm will be offered access to the chatbot after the end of the study.

Interventions

AI-assisted integrated care BEHAVIORAL

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.

AICC intervention group

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who test positive on either the Colorectal Cancer Risk Assessment Scale or the fecal immunochemical test (FIT);
• Aged 40 \~ 64 years;
• Proficient in smartphone use and able to engage with the intervention;
• Provided informed consent .

You may not qualify if:

• History of colorectal cancer;
• Contraindications to colonoscopy,(e.g. severe cardiac, cerebral, lung diseases, or renal dysfunction).

Sponsors & Collaborators

• Fudan University: lead
• Sun Yat-sen University: collaborator
• Shandong University: collaborator
• Shandong Cancer Hospital and Institute: collaborator

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhiyuan Hou, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyuan Hou, PhD

CONTACT

86+21 54231112; zyhou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share