CRC, Colorectal CancerNCT06261008
Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening
A study testing TI group in people with CRC, Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC, Colorectal Cancer
- What is being tested?
- TI group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2024to 26 Jun 2026
- 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
- already enrolled in the Program with negative FIT results in 2022
- eligible for the Program inclusion and due for repeat FIT screening in 2024
- either the participants themselves or their family members / caregivers have access to and agree to be contacted via WhatsApp
- ability to understand Chinese
Who cannot join
- who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded
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: Utilization of a Theory-driven, Culturally Tailored, Social Media-based, Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening: A Randomized Controlled Trial
In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour.
Read the detailed description
Eligible subject will be randomised to either the TI group or SC group. All subjects will receive an automated SMS text reminder delivered by the Program as the standard care.
Subjects randomized to the TI group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status.
Subjects will be invited to participate in four focus group discussions to elucidate how the study intervention influences repeat FIT adherence behaviours, explore the complexity of regular FIT screening, and reveal, based on the participants' accounts, the barriers to and facilitators of their adherence to the repeat FIT screening. The discussion will be audiotaped.
- Conditions
- CRC, Colorectal Cancer
- Being tested
- TI group
- 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.
TI groupBehavioural
CRC screening is arranged by referring the participants to the government-subsidized population-based CRC screening program. Our center is a PCP clinic offering FIT screenings under the Program. Colonoscopy is arranged if the FIT result is positive. Participants are instructed to repeat FIT at any PCP clinic 2 years after receiving a negative result. Based on the 34% local FIT screening adherence rate under SC and the assumption of improved FIT adherence to 49% after interactive TI, a minimum sample size of 332 subjects (166 per group) is required to achieve a statistical significance of p<0.05 and power of 80%. Assuming that 10% of the subjects will drop out, be lost to follow-up, or have incomplete chatbot conversations, the required sample size is rounded up to 370 (185 per group)
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. |
| Telehealth Intervention group | Experimental | Subjects randomized to the Telehealth Intervention (TI) group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status. Receives: Behavioral: TI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence rate
The primary outcome will be the repeat FIT screening adherence rate defined as returning completed FIT kits within 3 months after the repeat FIT due date in 2024.
Measured: 3 months
Secondary outcomes (5)
the number of days to repeat FIT
the number of days to participate in (FIT kits collection date to intervention date) and complete the repeat FIT screening after the intervention (completed FIT kits return date to intervention date)
Measured: 6 months
costs incurred in each study arm
including the cost of chatbot development, video production and the standard care of SMS reminder
Measured: 6 months
uptake rate in positive FIT
For those who have positive FIT, we will also assess their uptake rate of colonoscopy following positive FIT
Measured: 12 months
detection rate in positive FIT
For those who have positive FIT, we will also assess the detection rate of advanced neoplasm as defined as at least one colorectal cancer or advanced adenoma (size ≥10 mm, tubulovillous or villous component, or high-grade dysplasia).
Measured: 12 months
qualitative factors associated with repeat FIT adherence
Subjects will be invited to join the focus group for assessing qualitative factors associated with repeat FIT adherence in the biennial population-based CRC screening program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jun 2024 (estimated)
- Primary completion26 Mar 2025 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC, 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 standard care or telehealth intervention group
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
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
- NCT06261008
- Sponsor's protocol ID
- 2023.553
- Status last verified
- May 2024
- First submitted
- 4 Dec 2023
- Last updated
- 17 May 2024
- 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 IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a Theory-driven, Culturally Tailored, Social Media-based, Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06261008
- Acronym / sponsor ID
- 2023.553
- Conditions
- CRC, Colorectal Cancer
- Keywords
- colorectal cancer, screening, fecal immunochemical test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 26 Mar 2025 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 15 Feb 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 ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour.
Detailed description
Eligible subject will be randomised to either the TI group or SC group. All subjects will receive an automated SMS text reminder delivered by the Program as the standard care.
Subjects randomized to the TI group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status.
Subjects will be invited to participate in four focus group discussions to elucidate how the study intervention influences repeat FIT adherence behaviours, explore the complexity of regular FIT screening, and reveal, based on the participants' accounts, the barriers to and facilitators of their adherence to the repeat FIT screening. The discussion will be audiotaped.
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 standard care or telehealth intervention group
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. |
| Telehealth Intervention group | Experimental | Behavioral: TI groupSubjects randomized to the Telehealth Intervention (TI) group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status. |
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
- already enrolled in the Program with negative FIT results in 2022
- eligible for the Program inclusion and due for repeat FIT screening in 2024
- either the participants themselves or their family members / caregivers have access to and agree to be contacted via WhatsApp
- ability to understand Chinese
Key exclusion criteria (1 listed)
- who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded
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 |
|---|---|---|
| TI groupCRC screening is arranged by referring the participants to the government-subsidized population-based CRC screening program. Our center is a PCP clinic offering FIT screenings under the Program. Colonoscopy is arranged if the FIT result is positive. Participants are instructed to repeat FIT at any PCP clinic 2 years after receiving a negative result. Based on the 34% local FIT screening adherence rate under SC and the assumption of improved FIT adherence to 49% after interactive TI, a minimum sample size of 332 subjects (166 per group) is required to achieve a statistical significance of p<0.05 and power of 80%. Assuming that 10% of the subjects will drop out, be lost to follow-up, or have incomplete chatbot conversations, the required sample size is rounded up to 370 (185 per group) | Behavioural | Telehealth Intervention group |
Primary outcome
adherence rate
Time frame: 3 months
The primary outcome will be the repeat FIT screening adherence rate defined as returning completed FIT kits within 3 months after the repeat FIT due date in 2024.
5 secondary outcomes
the number of days to repeat FIT
Time frame: 6 months
costs incurred in each study arm
Time frame: 6 months
uptake rate in positive FIT
Time frame: 12 months
detection rate in positive FIT
Time frame: 12 months
qualitative factors associated with repeat FIT adherence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No. There will be no plan to share IPD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI group in people with CRC, 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 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Sia (26370428, felixsia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024.