AI-assisted Integrated Care to Promote Colonoscopy Uptake
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-64
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 .
Disqualifiers
History of colorectal cancer;
Contraindications to colonoscopy,(e.g. severe cardiac, cerebral, lung diseases, or renal dysfunction).
Trial design
Design model
Parallel
Treatments tested in this trial
AI-assisted integrated care
BehavioralA 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: AICC intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Uptake of colonoscopy
Whether participants receive colonoscopy for colorectal cancer screening.Data will be collected from information system of hospitals.
Time frame
Three and six months after recruitment2
Time to completion of colonoscopy
The interval from intervention initiation to the colonoscopy procedure. Data will be collected from information systems of hospitals.
Time frame
Six months after recruitmentSecondary outcomes
1
CRC screening literacy
CRC screening literacy will be assessed using a "Colorectal Cancer Screening Literacy Questionnaire" developed by the research team to ensure alignment with the study aims and intervention. The questionnaire comprises of 7 items , covering the basic knowledge of CRC, screening methods, benefits, and common misconceptions. Each item is answered with "yes", "no", and "not sure", with one point for a correct answer and no points for "not sure" and incorrect answers. The total score ranges from 0 to 7, and the higher the score, the higher the literacy level of the participants about CRC screening.
Time frame
One month after recruitment2
CRC screening belief
Participants' perceptions of CRC risk and their beliefs regarding benefits and barriers of colonoscopy will be assessed using a 5-point Likert scale (from "completely disagree" to "completely agree"). A higher score indicates a stronger belief.
Time frame
One month after recruitment3
Colonoscopy behavioral intention
Participants' intention to receive colonoscopy will be measured using a 5-point Likert scale (from "completely disagree" to "completely agree"). Those who agree or completely agree are defined as having colonoscopy intention.
Time frame
One month after recruitment4
User engagement level with chatbot
Chatbot engagement level is measured by a binary variable whether users highly engage with chatbot in terms of usage frequency, usage duration, the number of asked questions, and the presence of free-text questions. High-engagement is defined as those using chatbot frequently and longer, and asking more questions and free-text questions; others are low-engagement.
Time frame
Six months after recruitmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
Sun Yat-sen University
Collaborator
Shandong University
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov
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