Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorChinese University of Hong Kong

About this 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 According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program.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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded

Trial design

Design model

Parallel

Treatments tested in this trial

  • TI group

    Behavioral

    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)

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Telehealth Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

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)

Time frame
6 months
2

costs incurred in each study arm

including the cost of chatbot development, video production and the standard care of SMS reminder

Time frame
6 months
3

uptake rate in positive FIT

For those who have positive FIT, we will also assess their uptake rate of colonoscopy following positive FIT

Time frame
12 months
4

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).

Time frame
12 months

Other outcomes

Sponsors and contacts

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