Colorectal Cancer ScreeningNCT06905782
Artificial Intelligence (AI) Technology May Help Patients to Understand Bowel Preparation Better Before They go for Colonoscopy.This Study Attempts to Leverage AI Chatbot in Counselling Patients to Improve Bowel Cleanliness, Reduce Anxiety as Well as Increase Procedural Satisfaction
A study testing AI chatbot study arm and Traditional counselling study arm in people with Colorectal Cancer Screening and Colon Polyps and Adenomas, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Traditional pre-colonoscopy counselling requires significant time from healthcare workers to explain procedures, limiting efficiency and patient turnover. Inadequate bowel preparation exacerbates this issue, leading to repeat procedures and increased costs. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening, Colon Polyps and Adenomas, Bowel Preparation Quality
- What is being tested?
- AI chatbot study arm and Traditional counselling study arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All scheduled colonoscopy with indication
- Adequate digital literacy
- Adequate language literacy with Malay and English language
Who cannot join
- Patients with memory impairment due to previous stroke, dementia or Alzheimer's disease
- Diagnosed with clinical anxiety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Medicine, The National University of Malaysia
Cheras, Kuala Lumpur, 56000
Nabil Mohammad Azmi, Doctor of General Surgery, +60122177050, nabil@ukm.edu.my
About this study
Official title: Prospective Single Blinded Randomized Control Trial on the Effectiveness of Using Large Language Model Artificial Intelligence Chatbot to Improve Boston Bowel Preparation Score (BBPS) for Colonoscopy Preparation
Traditional pre-colonoscopy counselling requires significant time from healthcare workers to explain procedures, limiting efficiency and patient turnover. Inadequate bowel preparation exacerbates this issue, leading to repeat procedures and increased costs. However, no study has yet evaluated the effectiveness of AI in improving the Boston Bowel Preparation Scale (BBPS) for colonoscopy preparation. By addressing this gap, AI chatbots could provide personalized guidance, reduce healthcare worker burden, improve preparation quality, and enhance patient experience.This research attempts to evaluate the effectiveness of using Artificial intelligence (AI) chat bot to improve bowel preparation, anxiety level and patient's satisfaction among colonoscopy patients in Hospital Tuanku Muhriz (HCTM), compared to conventional instructions
- Conditions
- Colorectal Cancer Screening, Colon Polyps and Adenomas, Bowel Preparation Quality, Artificial Intelligence (AI)
- Being tested
- AI chatbot study arm, Traditional counselling study arm
- Keywords
- colorectal cancer, colon polyp, colonoscopy, bowel preparation, Boston Bowel Preparation Score (BBPS), artificial intelligence, AIChatbot, large language model, patient satisfaction, cancer screening
- Medical subject headings
- Colonic Polyps, Adenoma, Colorectal Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI chatbot study armProcedure or surgery
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)
Traditional counselling study armProcedure or surgery
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence (AI) Chatbot | Experimental | Patient's who will be interacting with AI chatbot for bowel preparation counselling Receives: Procedure: AI chatbot study arm; Procedure: Traditional counselling study arm |
| Conventional counselling by healthcare workers | Other | Patients receiving conventional way of counselling for bowel preparation before colonoscopy Receives: Procedure: AI chatbot study arm; Procedure: Traditional counselling study arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of artificial intelligence (AI) chat bot in improving bowel preparation among colonoscopy patients in Hospital Tuanku Mukhriz (HCTM), compared to conventional instructions
Patients in interventional arm will be receiving counselling via interaction with AI chatbot.Each interaction session were limited to 15 minutes maximum. The quality of bowel preparation will be graded by the masked endoscopists using Boston Bowel Preparation Score (BBPS). Each of the three colon segments (right, transverse and left) will be assigned scores (0 - 3) . 0 - unprepared colon while 3 indicates the best possible preparation.A total score will range from 0 to 9, where higher scores indicate better bowel preparation.
Measured: 1 year
Secondary outcomes (2)
To determine the effectiveness of AI chat bot in relieving anxiety among colonoscopy patients in HCTM, compared to conventional instructions.
Anxiety level for both arms will be measured before and after colonoscopy using the validated Depression Anxiety and Stress Scale 21 (Anxiety Scale). Is a self-reporting scale that measure the the anxiety.DASS interpretation ;Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19 and Extremely severe 20+
Measured: 1 year
To determine the effectiveness of AI chat bot in improving satisfaction among colonoscopy patients in HCTM, compared to conventional instructions.
Patients from both arms will be interviewed after colonoscopy using the validated Patient Satisfaction Questionnaire (PSQ).PSQ are a set of questionnaires that help researchers to understand patient experiences and identify areas of improvement.Patients will be evaluated on multiple domains- general satisfaction, technical quality, interpersonal aspect, clarity of communication,access to care and confidence in healthcare provider. Each domain will be given scores according to the Likert scale ranging from 1 to 5. 1 means very dissatisfied while 5 means very satisfied.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-masked, randomized control trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mohammad Azmi, National University of Malaysia
- Investigators
- Nabil Mohammad Azmi, Doctor of General Surgery, Principal investigator, Faculty of Medicine, The National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905782
- Sponsor's protocol ID
- JEP-2025-035
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol , Informed Consent Form, Clinical Study Report upon considerable request
Publications
Mohammad Azmi N, Abdul Jalal MI, Mohd Ashar SH, Mohd Nazri MI, Jie Y, Ganeson N, Augustine JK, Qian YS. A prospective single-masked, non-inferiority, parallel-group randomized controlled trial of the efficacy of a ChatGPT-based AI chatbot to improve Boston bowel preparation scores for colonoscopy preparation: A trial protocol. PLoS One. 2025 Oct 15;20(10):e0334349. doi: 10.1371/journal.pone.0334349. eCollection 2025.
PubMed 41091774
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Blinded Randomized Control Trial on the Effectiveness of Using Large Language Model Artificial Intelligence Chatbot to Improve Boston Bowel Preparation Score (BBPS) for Colonoscopy Preparation
- ClinicalTrials.gov ID
- NCT06905782
- Acronym / sponsor ID
- JEP-2025-035
- Conditions
- Colorectal Cancer Screening, Colon Polyps and Adenomas, Bowel Preparation Quality, Artificial Intelligence (AI)
- Keywords
- colorectal cancer, colon polyp, colonoscopy, bowel preparation, Boston Bowel Preparation Score (BBPS), artificial intelligence, AIChatbot, large language model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditional pre-colonoscopy counselling requires significant time from healthcare workers to explain procedures, limiting efficiency and patient turnover. Inadequate bowel preparation exacerbates this issue, leading to repeat procedures and increased costs. However, no study has yet evaluated the effectiveness of AI in improving the Boston Bowel Preparation Scale (BBPS) for colonoscopy preparation. By addressing this gap, AI chatbots could provide personalized guidance, reduce healthcare worker burden, improve preparation quality, and enhance patient experience.This research attempts to evaluate the effectiveness of using Artificial intelligence (AI) chat bot to improve bowel preparation, anxiety level and patient's satisfaction among colonoscopy patients in Hospital Tuanku Muhriz (HCTM), compared to conventional instructions
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Prospective, single-masked, randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence (AI) Chatbot | Experimental | Procedure: AI chatbot study arm, Procedure: Traditional counselling study armPatient's who will be interacting with AI chatbot for bowel preparation counselling |
| Conventional counselling by healthcare workers | Other | Procedure: AI chatbot study arm, Procedure: Traditional counselling study armPatients receiving conventional way of counselling for bowel preparation before colonoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All scheduled colonoscopy with indication
- Adequate digital literacy
- Adequate language literacy with Malay and English language
Key exclusion criteria (2 listed)
- Patients with memory impairment due to previous stroke, dementia or Alzheimer's disease
- Diagnosed with clinical anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI chatbot study armIntervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans) | Procedure or surgery | Artificial Intelligence (AI) Chatbot, Conventional counselling by healthcare workers |
| Traditional counselling study armIntervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans) | Procedure or surgery | Artificial Intelligence (AI) Chatbot, Conventional counselling by healthcare workers |
Primary outcome
To determine the effectiveness of artificial intelligence (AI) chat bot in improving bowel preparation among colonoscopy patients in Hospital Tuanku Mukhriz (HCTM), compared to conventional instructions
Time frame: 1 year
Patients in interventional arm will be receiving counselling via interaction with AI chatbot.Each interaction session were limited to 15 minutes maximum. The quality of bowel preparation will be graded by the masked endoscopists using Boston Bowel Preparation Score (BBPS). Each of the three colon segments (right, transverse and left) will be assigned scores (0 - 3) . 0 - unprepared colon while 3 indicates the best possible preparation.A total score will range from 0 to 9, where higher scores indicate better bowel preparation.
2 secondary outcomes
To determine the effectiveness of AI chat bot in relieving anxiety among colonoscopy patients in HCTM, compared to conventional instructions.
Time frame: 1 year
To determine the effectiveness of AI chat bot in improving satisfaction among colonoscopy patients in HCTM, compared to conventional instructions.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 41091774Mohammad Azmi N, Abdul Jalal MI, Mohd Ashar SH, Mohd Nazri MI, Jie Y, Ganeson N, Augustine JK, Qian YS. A prospective single-masked, non-inferiority, parallel-group randomized controlled trial of the efficacy of a ChatGPT-based AI chatbot to improve Boston bowel preparation scores for colonoscopy preparation: A trial protocol. PLoS One. 2025 Oct 15;20(10):e0334349. doi: 10.1371/journal.pone.0334349. eCollection 2025.
- Individual participant dataSharing planned: Yes. Study Protocol , Informed Consent Form, Clinical Study Report upon considerable request
Related trials for Colorectal Cancer Screening
Active, not recruiting
Guardant Shield Colorectal Cancer Screening
Colorectal Cancer
Not yet recruiting
Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia
CRC Screening
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Not yet recruiting
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Recruiting
Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
CRC Screening, Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabil Mohammad Azmi, Doctor of General Surgery principal investigator
Faculty of Medicine, The National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI chatbot study arm and Traditional counselling study arm in people with Colorectal Cancer Screening and Colon Polyps and Adenomas, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil Mohammad Azmi, Doctor in General Surgery (+60122177050, nabil@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effectiveness of artificial intelligence (AI) chat bot in improving bowel preparation among colonoscopy patients in Hospital Tuanku Mukhriz (HCTM), compared to conventional instructions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.