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Completed

NCT Number: NCT06192862

Effectiveness of Using Mobile Health Technology in Colorectal Cancer Screening Uptake

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Digestive Health, Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Assessment of screening intention and Transtheoretical Model stages for CRC screening

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. CRC screening uptake rate at 6 months

    Time frame: during the study period up to six 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

  2. time interval

    Time frame: during the study period up to six months

    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)

  3. qualitative factors checklist associated with CRC screening

    Time frame: during the study period up to six months

    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

  4. Likert scale

    Time frame: during the study period up to six months

    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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effectiveness of Theory-based Outreach Using Mobile Health Technology in Colorectal Cancer Screening Uptake: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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