Colorectal CancerNCT06192862
Effectiveness of Using Mobile Health Technology in Colorectal Cancer Screening Uptake
A study testing Assessment of screening intention and Transtheoretical Model stages for CRC screening in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In Hong Kong, colorectal cancer (CRC) ranked second in both cancer incidence and mortality. The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Assessment of screening intention and Transtheoretical Model stages for CRC screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-75 years old
- asymptomatic and eligible to enroll in a government-subsidized colorectal cancer screening program
- subjects themselves or their family members living in the same household with access to WhatsApp Messenger
- able to read Chinese
- willingness to be followed up by telephone
Who cannot join
- subject without access to WhatsApp Messenger
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre of Digestive Health, Prince of Wales Hospital
Hong Kong
About this study
Official title: Effectiveness of Theory-based Outreach Using Mobile Health Technology in Colorectal Cancer Screening Uptake: a Randomized Controlled Trial
In Hong Kong, colorectal cancer (CRC) ranked second in both cancer incidence and mortality.
The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.
Read more
Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021.
Similar to colonoscopy screening outreach, FIT screening can be done by providing contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange it. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.
Moreover, CRC screening uptake is highly associated with Health Belief Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.
Therefore, we will develop a theory-based mobile messenger-initiated chatbot and conduct a randomized controlled trial to evaluate its performance in improving the CRC screening uptake when compared to standard text reminders.
Read the detailed description
In Hong Kong, Colorectal cancer (CRC) ranked second in both cancer incidence and mortality, accounting for 16.7% of all new cancer cases and 14.6% of all cancer-related deaths in 2019. There was a staggering 2.5-fold increase in the number of newly diagnosed CRC cases from 1584 to 2019.
The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.
Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021. Efforts have been made to increase the rate. Outreach is the active dissemination of screening outside of the primary care setting, and it also includes mailing, texting, and calling to encourage scheduling of screening procedures.
It was technically infeasible to conduct fecal test outreach by mailing the test kits in Hong Kong because the government-subsidized colorectal cancer screening program required consultation with a primary care physician to assess the subjects' health condition, and their eligibility before distributing the fecal test kits. Similar to colonoscopy screening outreach, an alternative method is to provide contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange a consultation for FIT screening. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.
Moreover, CRC screening uptake is highly associated with Health Belife Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.
The CRC screening uptake rate in Hong Kong was 10%, and there is no established evidence to increase the uptake rate of FIT screening for CRC by outreach using mobile health technology or psychological theory-based interventions. A theory-based mobile messenger-initiated chatbot is a potential solution to this problem.
Therefore, we will develop a theory-based mobile messenger-initiated chatbot and conduct a randomized controlled trial to evaluate its performance in improving the CRC screening uptake when compared to standard text reminders.
- Conditions
- Colorectal Cancer
- Being tested
- Assessment of screening intention and Transtheoretical Model stages for CRC screening
- Keywords
- colorectal cancer, screening, fecal immunochemical test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of screening intention and Transtheoretical Model stages for CRC screeningBehavioural
Screening Intentions will be measured by asking the subject, ""How much do you agree or disagree: I am intending to have colon cancer screening within the next 6 months". Subjects who "strongly disagrees" or "somewhat disagrees" are considered not having screening intention. Subjects who "somewhat agrees" or "strongly agrees" are considered having screening intention. For subjects who has screening intention, they will be asked if they have plan to arrange a consultation with primary care physician to collect FIT kits in next 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Text reminder group (control) | No intervention | Randomized subjects to the text reminder group will be asked about their intention to undergo CRC screening in the next 6 months. For those who are at pre-contemplation and contemplation stage, a standard text message will be delivered to invite them to undergo CRC screening by informing them that they are due to CRC screening because they are aged >50 years and are yet to receive CRC screening. No HBM-based health education video or personalized risk assessment will be provided. The chatbot then asks the subject's intention to undergo CRC screening again. For those who propelled to preparation stage or those who are at preparation stage at the beginning, the website link of the government-subsidized CRC screening program which lists the names of all primary care physicians and their contact and co-payment information will be provided. |
| Chatbot outreach group | Experimental | Subjects in chatbot outreach group will be asked about their intention to undergo CRC screening in the next 6 months and their TTM stage will be determined according to their answers. For subjects who are at preparation stage, the chatbot will further request for the preferred district to have a consultation under the government-subsidized CRC screening.
For subjects who are at pre-contemplation stage, the chatbot will deliver an HBM-based health education video filmed by gastroenterologists and colorectal cancer survivor who has been diagnosed by screening. The subject's intention will be asked again after the video.
For those who upgrade to contemplation stage or remain at pre-contemplation stage and those who are at contemplation stage at the beginning, the chatbot will assess the personalized risk of CRC using the Asia-Pacific Colorectal Screening Score (APCS). Finally, the subject's intention to undergo screening will be asked for the last time. Receives: Behavioral: Assessment of screening intention and Transtheoretical Model stages for CRC screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening uptake rate at 3 months
The primary outcome is the CRC screening uptake rate, defined as participation in and completion of the government-subsidized CRC screening program by returning valid FIT kits at three months after intervention
Measured: during the study period up to three months
Secondary outcomes (4)
CRC screening uptake rate at 6 months
The primary outcome is the CRC screening uptake rate, defined as participation in and completion of the government-subsidized CRC screening program by returning valid FIT kits at six months after intervention
Measured: during the study period up to six months
time interval
time interval to participate (Date of FIT kits collection minus date of study intervention) and complete screening after recruitment (Date of return of valid FIT kit minus date of study intervention)
Measured: during the study period up to six months
qualitative factors checklist associated with CRC screening
reason for not participating in screening (common local barriers to CRC screening, including, financial difficulty, limited services accessibility, screening-induced bodily discomfort, physical harm, embarrassment, apprehension, time constraints and others) checklist
Measured: during the study period up to six months
Likert scale
baseline intention of CRC screening before intervention, measured by 4 point Likert scale (1 = strongly disagree; 2 = somewhat disagree; 3 = somewhat agree and 4 = strongly agree) and the change in screening intent immediately after each intervention, evaluated by calculating point difference between pre- and post-intervention
Measured: during the study period up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jul 2024
- Primary completion31 Jan 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be randomized into either Text reminder (control) group or Chatbot outreach group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Yuen Tung Lam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192862
- Sponsor's protocol ID
- 2022.614
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no plan to share Individual participant data
Publications
Tung Lam TY, To Z, Wang ZJ, Han Mo PK, Lau WM, Yi Y, Raymond Tang SY, Hu Y, Wu X, Dong D, Helen Meng ML, Shan Wong SY, Yiu Sung JJ. Effectiveness of Theory-Based WhatsApp Chatbot Outreach in Colorectal Cancer Screening Uptake: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Aug 19:S1542-3565(26)00597-5. doi: 10.1016/j.cgh.2026.08.006. Online ahead of print.
PubMed 42617827Hu Y, Lau WM, Wang ZJ, Tang RSY, Wu X, Mo PKH, Wong SYS, Meng MLH, Dong D, Sung JJY, Lam TYT. Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial. BMJ Open. 2025 Jul 10;15(7):e103857. doi: 10.1136/bmjopen-2025-103857.
PubMed 40639841
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Theory-based Outreach Using Mobile Health Technology in Colorectal Cancer Screening Uptake: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06192862
- Acronym / sponsor ID
- 2022.614
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, screening, fecal immunochemical test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 5 Jan 2024 (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.
In Hong Kong, colorectal cancer (CRC) ranked second in both cancer incidence and mortality.
The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.
Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021.
Similar to colonoscopy screening outreach, FIT screening can be done by providing contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange it. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.
Moreover, CRC screening uptake is highly associated with Health Belief Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.
Therefore, we will develop a theory-based mobile messenger-initiated chatbot and conduct a randomized controlled trial to evaluate its performance in improving the CRC screening uptake when compared to standard text reminders.
Detailed description
In Hong Kong, Colorectal cancer (CRC) ranked second in both cancer incidence and mortality, accounting for 16.7% of all new cancer cases and 14.6% of all cancer-related deaths in 2019. There was a staggering 2.5-fold increase in the number of newly diagnosed CRC cases from 1584 to 2019.
The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.
Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021. Efforts have been made to increase the rate. Outreach is the active dissemination of screening outside of the primary care setting, and it also includes mailing, texting, and calling to encourage scheduling of screening procedures.
It was technically infeasible to conduct fecal test outreach by mailing the test kits in Hong Kong because the government-subsidized colorectal cancer screening program required consultation with a primary care physician to assess the subjects' health condition, and their eligibility before distributing the fecal test kits. Similar to colonoscopy screening outreach, an alternative method is to provide contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange a consultation for FIT screening. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.
Moreover, CRC screening uptake is highly associated with Health Belife Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.
The CRC screening uptake rate in Hong Kong was 10%, and there is no established evidence to increase the uptake rate of FIT screening for CRC by outreach using mobile health technology or psychological theory-based interventions. A theory-based mobile messenger-initiated chatbot is a potential solution to this problem.
Therefore, we will develop a theory-based mobile messenger-initiated chatbot and conduct a randomized controlled trial to evaluate its performance in improving the CRC screening uptake when compared to standard text reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient will be randomized into either Text reminder (control) group or Chatbot outreach group
| Arm | Type | Receives |
|---|---|---|
| Text reminder group (control) | No intervention | –Randomized subjects to the text reminder group will be asked about their intention to undergo CRC screening in the next 6 months. For those who are at pre-contemplation and contemplation stage, a standard text message will be delivered to invite them to undergo CRC screening by informing them that they are due to CRC screening because they are aged >50 years and are yet to receive CRC screening. No HBM-based health education video or personalized risk assessment will be provided. The chatbot then asks the subject's intention to undergo CRC screening again. For those who propelled to preparation stage or those who are at preparation stage at the beginning, the website link of the government-subsidized CRC screening program which lists the names of all primary care physicians and their contact and co-payment information will be provided. |
| Chatbot outreach group | Experimental | Behavioral: Assessment of screening intention and Transtheoretical Model stages for CRC screeningSubjects in chatbot outreach group will be asked about their intention to undergo CRC screening in the next 6 months and their TTM stage will be determined according to their answers. For subjects who are at preparation stage, the chatbot will further request for the preferred district to have a consultation under the government-subsidized CRC screening. For subjects who are at pre-contemplation stage, the chatbot will deliver an HBM-based health education video filmed by gastroenterologists and colorectal cancer survivor who has been diagnosed by screening. The subject's intention will be asked again after the video. For those who upgrade to contemplation stage or remain at pre-contemplation stage and those who are at contemplation stage at the beginning, the chatbot will assess the personalized risk of CRC using the Asia-Pacific Colorectal Screening Score (APCS). Finally, the subject's intention to undergo screening will be asked for the last time. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50-75 years old
- asymptomatic and eligible to enroll in a government-subsidized colorectal cancer screening program
- subjects themselves or their family members living in the same household with access to WhatsApp Messenger
- able to read Chinese
- willingness to be followed up by telephone
Key exclusion criteria (2 listed)
- subject without access to WhatsApp Messenger
- unable to provide informed consent
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 |
|---|---|---|
| Assessment of screening intention and Transtheoretical Model stages for CRC screeningScreening Intentions will be measured by asking the subject, ""How much do you agree or disagree: I am intending to have colon cancer screening within the next 6 months". Subjects who "strongly disagrees" or "somewhat disagrees" are considered not having screening intention. Subjects who "somewhat agrees" or "strongly agrees" are considered having screening intention. For subjects who has screening intention, they will be asked if they have plan to arrange a consultation with primary care physician to collect FIT kits in next 3 months. | Behavioural | Chatbot outreach group |
Primary outcome
CRC screening uptake rate at 3 months
Time frame: during the study period up to three months
The primary outcome is the CRC screening uptake rate, defined as participation in and completion of the government-subsidized CRC screening program by returning valid FIT kits at three months after intervention
4 secondary outcomes
CRC screening uptake rate at 6 months
Time frame: during the study period up to six months
time interval
Time frame: during the study period up to six months
qualitative factors checklist associated with CRC screening
Time frame: during the study period up to six months
Likert scale
Time frame: during the study period up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 42617827Tung Lam TY, To Z, Wang ZJ, Han Mo PK, Lau WM, Yi Y, Raymond Tang SY, Hu Y, Wu X, Dong D, Helen Meng ML, Shan Wong SY, Yiu Sung JJ. Effectiveness of Theory-Based WhatsApp Chatbot Outreach in Colorectal Cancer Screening Uptake: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Aug 19:S1542-3565(26)00597-5. doi: 10.1016/j.cgh.2026.08.006. Online ahead of print.
- Derived from this study: PubMed 40639841Hu Y, Lau WM, Wang ZJ, Tang RSY, Wu X, Mo PKH, Wong SYS, Meng MLH, Dong D, Sung JJY, Lam TYT. Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial. BMJ Open. 2025 Jul 10;15(7):e103857. doi: 10.1136/bmjopen-2025-103857.
- Individual participant dataSharing planned: No. There will be no plan to share Individual participant data
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of screening intention and Transtheoretical Model stages for CRC screening in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 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: finished, as of the sponsor's last update on 3 Jun 2026. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC screening uptake rate at 3 months (time frame: during the study period up to three months). 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 NCT06192862, which also lists 2 linked publications.
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 3 Jun 2026.