None listed
Conditions
Brief summary
Colorectal Cancer (CRC), the third most common cancer in Malaysia, is a preventable disease if screened early. Health Education Module (HEAMOD) developed in accordance with the Preventive Health Model (PHM) framework is particularly useful in increasing screening uptake among health-insured workers and can improve productivity. The main objective of this study is to assess the effect of PHM-based health education module on CRC screening uptake using Faecal Immunochemical Test (FIT) among Social Security Organisation (SOCSO) health-insured workers in Kuantan. A parallel, two arms, single-blind, cluster randomized trial utilizing stratified block randomization will be conducted, involving 12 workplace clusters of 32 workers in each. The intervention group receives HEAMOD comprising of group education, a practical session on FIT and WhatsApp group follow-up, while the control group receives CRC brochure. A validated questionnaire will be used to assess participant’s background characteristics, risk factors, signs and symptoms, knowledge on CRC, attitude on CRC and acceptability of FIT. Validated weighing scale and stadiometer will be used for body mass index measurements. FIT will be used as the CRC screening tool. Descriptive and inferential statistics will be applied for data analysis using IBM Statistical Package for Social Sciences version 22. Longitudinal correlated data on knowledge, attitude and acceptability score at baseline, immediate post intervention and 3 months post-intervention will be analyzed using generalized linear mixed model (GLMM). FIT uptake and its trend at immediate post intervention and 3 months post-intervention will be analyzed using GLMM and repeated measure Analysis of Variance (ANOVA) trend analysis, respectively. It is expected that CRC screening uptake rate is more in the intervention group as compared to the control group, indicating the effectiveness of the HEAMOD. Positive individuals for FIT will be referred to a specialist for further evaluation, while, negative individuals will be given reassurance. It is hoped that the HEAMOD and CRC screening could potentially be included in SOCSO Health Screening Programme for workers’ health benefit in the long-run.
Interventions
The intervention arm will receive health education module (HEAMOD). It is specifically developed for this study, using the Preventive Health Model (PHM) and diffusion of innovation theory (DIT), which consist of: group education, practical session on fecal immunochemical test (FIT) and WhatsApp group follow-up. For group education, there will be 2 methods of group education delivery. First,a 2 hour health talk will be given by the researcher in the form of a Power Point presentation. The PowerPo
The intervention arm will receive health education module (HEAMOD). It is specifically developed for this study, using the Preventive Health Model (PHM) and diffusion of innovation theory (DIT), which consist of: group education, practical session on fecal immunochemical test (FIT) and WhatsApp group follow-up. For group education, there will be 2 methods of group education delivery. First,a 2 hour health talk will be given by the researcher in the form of a Power Point presentation. The PowerPoint will be constructed together with a consultant colorectal surgeon for content verification. This will focus on giving awareness of the relative advantage of the FIT. The first PowerPoint presentation will focus on the background on colorectal cancer (CRC) and importance of early screening. The second PowerPoint presentation will focus on treatment options should they be positive of the FIT. The second mode of delivery would be a group discussion, lasting 2 hours. Participants will be divided into several small groups. With the help of enumerators, barriers and obstacles in taking up screening will be explored. Further reinforcement of CRC screening knowledge will be given. The participant will be assisted if any issue or question arises. This will cover the key constructs in the PHM which are perceived susceptibility, perceived barriers, perceived benefits, social influence and self-efficacy, in addition to knowledge component. For practical session on FIT, there will be a demonstration on FIT by enumerators consisting of healthcare workers to show how to do the test in a correct manner, lasting 1 hour. Participants will be asked to take 2 faecal samples for 2 consecutive days. These samples will be collected within 3 months after the practical session on FIT is done. This will test for four DIT constructs on the acceptability of FIT which are relative advantage, complexity, compatibility and trial ability. Lastly, there will be a WhatsApp group follow-up. Every follow-up of the trial will be communicated using WhatsApp. Once a week, a reminder mechanism will be implemented to remind participants to do the screening and return it to the research team as soon as possible. In addition, those who have done the test will report to the WhatsApp group, facilitating those who have not done it to do the test too. This covers the domain of observability in the DIT. The overall duration for the intervention is 3 months.
Sponsors
Universiti Putra Malaysia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Organizations with SOCSO-insured workers in Kuantan, Pahang 2. Malaysian citizen aged 18 years and above
Exclusion criteria
Participants who have ever been diagnosed with CRC before the date data collection starts
Outcome results
None listed