A hybrid patient decision aid integrating a large language model-powered chatbot to improve colorectal cancer diagnostic uptake

ISRCTN	ISRCTN14407050
DOI	https://doi.org/10.1186/ISRCTN14407050
Sponsor	National Health Commission of the People's Republic of China
Funder	National Health Commission of the People's Republic of China

Submission date: 15/01/2026
Registration date: 04/02/2026
Last edited: 22/09/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yan Wei
Scientific, Principal investigator, Public

Fudan University
Shanghai
200032
China

Phone	+86 (0)18930749707
Email	yanwei@fudan.edu.cn

Mr Haichuan Guo
Public

Fudan University
Shanghai
200032
China

Phone	+86 (0)18669462376
Email	24211020126@m.fudan.edu.cn

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Diagnostic, Health services research
Scientific title	Design and effectiveness evaluation of a hybrid patient decision support system integrating an integrated large language model chatbot for improving the compliance of community residents with colorectal cancer diagnosis: A study based in Shanghai, China
Study objectives
Ethics approval(s)	Approved 13/01/2026, Ethics Committee of the School of Public Health (Fudan University, Shanghai, 200032, China; +86 (0)21 5423 7148; gwkyb@fudan.edu.cn), ref: H2026009
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	Current interventions as of 22/09/2026: Participants allocated to the intervention group will receive the multicomponent PDAs intervention when they attend the Community Healthcare Center (CHC) to collect their CRC screening results. Trained investigators will introduce the printed desk calendar, explain its content, demonstrate how to use the LLM-based interactive consultation module on a smartphone, and assist participants in subscribing to the WeChat Official Account. Following enrollment, the WeChat Official Account will serve as the digital platform for continuous intervention. In addition to providing access to the LLM-based interactive consultation module, the platform will deliver CRC-related health education and diagnostic guidance every two weeks, thereby providing ongoing behavioral support and reinforcing participants' motivation to undergo timely diagnostic evaluation. Participants allocated to the control group will receive routine care according to the existing CRC screening program. When collecting their screening results at the CHC, they will receive the standard recommendation from their GP to undergo further diagnostic evaluation. No additional intervention beyond routine care will be provided to the control group. All participants obtained informed consent from their GP teams before being enrolled in the study. _____ Previous interventions: Study sites were randomly assigned to either a digital decision aid intervention group or a usual care control group. The intervention consisted of two components: 1. Training for Healthcare Providers: Medical staff in the intervention group received a 4–5 hour training session on using the decision aid and related clinician-patient communication skills prior to implementation. 2. Digital Decision Aid Implementation: The digital tool was used during outpatient colorectal cancer screening consultations to support the pre-colonoscopy decision-making process. Its primary content involved educating residents about colorectal cancer and colonoscopy screening.
Intervention type	Behavioural
Primary outcome measure(s)	CRC diagnostic uptake measured using telephone follow-up survey at 3 months post-intervention CRC diagnostic uptake measured using telephone follow-up survey at 6 months post-intervention Quality-adjusted life years (QALYs) measured using patient records at 3 months post-intervention Intervention costs measured using patient records at 3 months post-intervention Previous primary outcome(s): 1. Decision whether to undergo colonoscopy screening measured using telephone follow-up survey at 3 months post-intervention
Key secondary outcome measure(s)	Current key secondary outcome(s) as of 22/09/2026: 1. Residents' knowledge and cognitive level, using a question-and-answer scale designed by the research team at baseline, immediately post-intervention, and 3 months post-intervention. Residents need to judge whether 10 descriptions about colorectal cancer and cancer screening diagnosis are correct, and their knowledge level will be determined based on the accuracy rate. 2. Decision conflict level, measured using the Chinese version of the Decisional Conflict Scale at baseline, immediately post-intervention, and 3 months post-intervention 3. Decision self-confidence, measured using the Chinese version of the Decision Self-Efficacy scale at baseline, immediately post-intervention, and 3 months post-intervention 4. Decision regret degree, measured using the Chinese version of the Decision Regret Scale at at 3 months post-intervention 5. Residents' satisfaction with the intervention tools, measured using the Chinese version of the Decision Preparation scale at 3 months post-intervention 6. Residents' expectations regarding shared decision-making measured using the Chinese version of the shared decision-making scale 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline and 3 months post-intervention _____ Previous key secondary outcome(s): 1. Residents' knowledge and cognitive level, using a question-and-answer scale designed by the research team at baseline, immediately post-intervention, and 3 months post-intervention. Residents need to judge whether 10 descriptions about colorectal cancer and cancer screening diagnosis are correct, and their knowledge level will be determined based on the accuracy rate. 2. Decision conflict level, measured using the Chinese version of the Decisional Conflict Scale at baseline, immediately post-intervention, and 3 months post-intervention 3. Decision self-confidence, measured using the Chinese version of the Decision Self-Efficacy scale at baseline, immediately post-intervention, and 3 months post-intervention 4. Decision regret degree, measured using the Chinese version of the Decision Regret Scale at at 3 months post-intervention 5. Residents' satisfaction with the intervention tools, measured using the Chinese version of the Decision Preparation scale at 3 months post-intervention 6. Diagnostic preference, measured using a self-designed scale at baseline, immediately post-intervention, and 3 months post-intervention 7. Residents' expectations regarding shared decision-making measured using the Chinese version of the shared decision-making scale 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline and 3 months post-intervention
Completion date	31/03/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	50 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	1000
Key inclusion criteria	Current key inclusion criteria as of 22/09/2026: 1. Aged 50–100 years and registered as local participants 2. Have a positive result from the most recent CRC screening 3. Have not undergone diagnostic evaluation following their most recent positive CRC screening result 4. Own a smartphone and have a personal WeChat account _____ Previous key inclusion criteria: 1. Permanent residents of Shanghai (including individuals with local household registration and non-local residents who have lived in Shanghai for over 6 months). 2. Individuals eligible according to the Shanghai Community Colorectal Cancer Screening Implementation Plan. 3. Individuals enrolled in any of Shanghai's basic medical insurance or healthcare security schemes.
Key exclusion criteria	Current key exclusion criteria as of 22/09/2026: 1. Have already been diagnosed with colorectal cancer 2. Cannot be contacted during the follow-up period 3. Have life-threatening illnesses or other serious medical conditions that may preclude study participation 4. Have cognitive impairment that prevents them from completing the study questionnaire _____ Previous key exclusion criteria: 1. Individuals who have previously undergone colonoscopy and were confirmed to be at no risk for colorectal cancer. 2. Individuals whose health status is unsuitable for colonoscopy. 3. Individuals with cognitive impairment that prevents participation in follow-up and questionnaire surveys. 4. Individuals with a confirmed diagnosis of colorectal cancer. 5. Individuals with a confirmed diagnosis of other high-risk diseases where the mortality risk is too high for them to be suitable for colonoscopy screening.
Date of first enrolment	01/03/2026
Date of final enrolment	30/09/2026

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

22/09/2026: The following changes were made to the study record:
1. The public title was changed from "Digital nudging for adherence to colonoscopy screening: a study based on the MINDSPACE framework" to "A hybrid patient decision aid integrating a large language model-powered chatbot to improve colorectal cancer diagnostic uptake".
2. The scientific title was changed from "Design and effectiveness evaluation of a digital nudging tool for improving colorectal cancer screening adherence among community residents: a case study of Shanghai, China" to "Design and effectiveness evaluation of a hybrid patient decision support system integrating an integrated large language model chatbot for improving the compliance of community residents with colorectal cancer diagnosis: A study based in Shanghai, China".
3. The Assignment was changed from Cluster to Parallel.
4. The Completion date was changed from 31/12/2026 to 31/03/2027.
5. The interventions were changed.
6. The primary outcome(s) were changed.
7. The key secondary outcome(s) were changed.
8. The key inclusion criteria were changed.
9. The key exclusion criteria were changed.
28/08/2026: The Date of final enrolment was changed from 31/08/2026 to 30/09/2026.
15/01/2026: Study's existence confirmed by the Ethics Committee of the School of Public Health.