Clinical trial NCT06261008: Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CRC, Colorectal Cancer
Keywords: colorectal cancer, screening, fecal immunochemical test
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 370
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be randomized into either standard care or telehealth intervention group
Primary purpose: HEALTH_SERVICES_RESEARCH

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 According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program.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

Eligibility criteria: 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

Primary outcomes:
measure: adherence rate
timeFrame: 3 months
Secondary outcomes:
measure: the number of days to repeat FIT
timeFrame: 6 months
measure: costs incurred in each study arm
timeFrame: 6 months
measure: uptake rate in positive FIT
timeFrame: 12 months
measure: detection rate in positive FIT
timeFrame: 12 months
measure: qualitative factors associated with repeat FIT adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre of Digestive Health, Prince of Wales Hospital
Study officials:
References: