WhatsApp Reminder on FIT Compliance
Primary Purpose
Colorectal Cancer, Screening Compliance, Fecal Immunochemical Test
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
WhatsApp reminder
Sponsored by

About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
WhatsApp reminder
No reminder
Arm Description
An interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening
Outcomes
Primary Outcome Measures
Compliance rate
Compliance rate of FIT in the year of receiving the interventions/control
Secondary Outcome Measures
Compliance rate of second round
Compliance rate of FIT in the year of second round of follow up after crossing over
Full Information
NCT ID
NCT03209765
First Posted
July 4, 2017
Last Updated
June 10, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03209765
Brief Title
WhatsApp Reminder on FIT Compliance
Official Title
Effectiveness of WhatsApp Reminder on Compliance of Colorectal Cancer Screening: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Screening Compliance, Fecal Immunochemical Test
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WhatsApp reminder
Arm Type
Active Comparator
Arm Description
An interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening
Arm Title
No reminder
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
WhatsApp reminder
Intervention Description
An interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening
Primary Outcome Measure Information:
Title
Compliance rate
Description
Compliance rate of FIT in the year of receiving the interventions/control
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Compliance rate of second round
Description
Compliance rate of FIT in the year of second round of follow up after crossing over
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yuen Tung Lam, MSc
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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WhatsApp Reminder on FIT Compliance
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