NCT06192862

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

June 3, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

December 11, 2023

Last Update Submit

May 31, 2026

Conditions

Keywords

colorectal cancerscreeningfecal immunochemical test

Outcome Measures

Primary Outcomes (1)

  • 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

    during the study period up to three months

Secondary Outcomes (4)

  • CRC screening uptake rate at 6 months

    during the study period up to six months

  • time interval

    during the study period up to six months

  • qualitative factors checklist associated with CRC screening

    during the study period up to six months

  • Likert scale

    during the study period up to six months

Study Arms (2)

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.

Behavioral: Assessment of screening intention and Transtheoretical Model stages for CRC screening

Interventions

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.

Chatbot outreach group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • subject without access to WhatsApp Messenger
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Digestive Health, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Hu 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There will no masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Patient will be randomized into either Text reminder (control) group or Chatbot outreach group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 5, 2024

Study Start

July 1, 2024

Primary Completion

January 31, 2025

Study Completion

November 30, 2025

Last Updated

June 3, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

There will be no plan to share Individual participant data

Locations