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Trial Title:
Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening
NCT ID:
NCT06261008
Condition:
CRC, Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer, screening, fecal immunochemical test
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patient will be randomized into either standard care or telehealth intervention group
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Masking description:
There will no masking
Intervention:
Intervention type:
Behavioral
Intervention name:
TI group
Description:
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)
Arm group label:
Telehealth Intervention group
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 According to unpublished data, despite SC, only 34% of participants adhere to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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Centre of Digestive Health, Prince of Wales Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Start date:
June 1, 2024
Completion date:
June 26, 2026
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06261008
