CRC, Colorectal Cancer
Conditions
Keywords
colorectal cancer, screening, fecal immunochemical test
Brief 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. 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 According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program.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.
Interventions
BEHAVIORALTI group
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)
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
There will no masking
Intervention model description
Patient will be randomized into either standard care or telehealth intervention group
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the number of days to repeat FIT | 6 months | 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) |
| costs incurred in each study arm | 6 months | including the cost of chatbot development, video production and the standard care of SMS reminder |
| uptake rate in positive FIT | 12 months | For those who have positive FIT, we will also assess their uptake rate of colonoscopy following positive FIT |
| detection rate in positive FIT | 12 months | 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). |
| qualitative factors associated with repeat FIT adherence | 12 months | 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 |
Countries
Hong Kong
Contacts
Primary ContactFelix Sia
Outcome results
None listed