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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209765
Other study ID # WhatsApp Compliance Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 16, 2017
Est. completion date December 31, 2019

Study information

Verified date June 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2014. Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 50. Fecal immunochemical tests (FIT), is one of the recommendation as first-line modality for CRC screening. Since yearly testing is recommended to maintain programmatic effectiveness longitudinal adherence is a critical component of FOBT-based screening programs. Our previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment8. In recent years, social media (SM) has become an increasingly popular source of health information. By providing an easily accessible and interactive channel of communication between reviewers and information providers, it has potential values for affecting public health. However, the effects of SM on the compliance of CRC screening by FIT has not yet been studied. WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized controlled study will investigate the effect of WhatsApp vs no reminder on the compliance of CRC screening by FIT.


Description:

It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2014. Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 50. Fecal immunochemical tests (FIT), is one of the recommendation as first-line modality for CRC screening. Since yearly testing is recommended to maintain programmatic effectiveness longitudinal adherence is a critical component of FOBT-based screening programs. Our previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment8. In recent years, social media (SM) has become an increasingly popular source of health information. By providing an easily accessible and interactive channel of communication between reviewers and information providers, it has potential values for affecting public health. However, the effects of SM on the compliance of CRC screening by FIT has not yet been studied. WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized controlled study will investigate the effect of WhatsApp vs no reminder on the compliance of CRC screening by FIT. All subjects will be recruited from the existing cohort of screening participants who joined the bowel cancer screening programme in the CUHK JC Bowel Cancer Education Centre in 2016 with FOBT negative in the first round of screening, and who are expected to follow-up and return to the centre in 2017 for their second round of FOBT screening. Each study subjects will be offered either an interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening; or usual care, where no additional intervention will be offered. A simple random sampling process will be administered using computer-generated numbers so that each participant will have a 50% probability for assignment into each group. All potential participants identified who are eligible for the study will be randomized by a computer randomizer, which will give a number indicating the group assigned. The outcome of interest included the proportion of subjects who return to the centre and retrieve faecal tubes for screening 30 days within the scheduled time for the second year of the screening test. To investigate the long-term effect of WhatsApp reminder on FIT compliance, all subjects in this study (except those died or had positive FIT result) will be called in the first quarter of 2019 and offered FIT again in a cross-over design in 2019, i.e. 1) patients initially randomized to WhatsApp reminder group in 2017 will receive no reminder in 2019; and 2) those randomized to no reminder group in 2017 will receive WhatsApp reminder in 2019.. The FIT pickup and return rate and reason of default will be recorded again.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria: - Subjects who joined the bowel cancer screening programme in the CUHK JC Bowel Cancer Education Centre and are expected to follow up for annual FIT. Exclusion Criteria: - Lack of access to WhatsApp Messenger

Study Design


Intervention

Other:
WhatsApp reminder
An interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance rate Compliance rate of FIT in the year of receiving the interventions/control 1 year
Secondary Compliance rate of second round Compliance rate of FIT in the year of second round of follow up after crossing over 3 years
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