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Trial registered on ANZCTR


Registration number
ACTRN12617000623392
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Cluster Randomized Trial Study on Effectiveness of Health Education Module
(HEAMOD) on Colorectal Cancer Screening Uptake among Workers in Kuantan District,
Pahang State, Malaysia
Scientific title
Effect of Health Education Module on Colorectal Cancer Screening Uptake using Preventive Health Model among Social Security Organization (SOCSO)-insured Workers in Kuantan
Secondary ID [1] 291378 0
Nil known
Universal Trial Number (UTN)
U1111-1193-9349
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 302403 0
Condition category
Condition code
Cancer 301975 301975 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 301976 301976 0 0
Health promotion/education
Public Health 301977 301977 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297424 0
Behaviour
Intervention code [2] 297425 0
Early detection / Screening
Intervention code [3] 297692 0
Prevention
Comparator / control treatment
The control group will receive a colorectal cancer (CRC) brochure developed by the research team. The brochure covers the background on CRC and screening using FIT. It is considered as the standard care, where the Ministry of Health Malaysia also provides CRC brochure as their health education material.
Control group
Active

Outcomes
Primary outcome [1] 301390 0
The primary outcome will be colorectal cancer (CRC) screening uptake. a. CRC screening uptake is defined as participants who agreed for screening and completed 2 consecutive FIT samples at immediate and 3 months post intervention. It is classified into yes or no. Thus, it is measured statistically using Generalized Linear Mixed Model (GLMM) as the proportion of screening uptake in each intervention and control group.
Timepoint [1] 301390 0
Immediate post intervention and 3 months post intervention
Primary outcome [2] 301391 0
Effectiveness, or CRC screening uptake rate. It is defined as the number of participants who have completed 2 consecutive FIT samples after 3 months post intervention following invitation agreement divided by all participants who agreed for screening. It is divided into sufficient (equal or more than 45%) and insufficient (less than 45%) (European Commission, EC, 2010). Sufficient CRC screening uptake rate indicates that the intervention is effective.
Timepoint [2] 301391 0
3 months post intervention
Secondary outcome [1] 332531 0
Fecal Immunochemical Test (FIT) outcome, defined as test result from participants who completed the screening, either positive or negative. In addition, positive FIT rate is defined as number of participants with a positive FIT test done within a defined time frame divided by number of participants adequately tested (EC, 2010).
Timepoint [1] 332531 0
3 months post intervention
Secondary outcome [2] 332532 0
Post intervention knowledge score, defined as the immediate and 3 months post intervention mean knowledge score obtained from the answer given by the respondents in section D of the knowledge, attitude and FIT acceptability (KAFA) questionnaire divided by the maximum possible score, and multiplied by 100 to get the percentage. It is measured using GLMM. The KAFA questionnaire contents were adapted from various studies and also designed specifically for this study. Section D was validated in a previous study elsewhere (Salimzadeh, Delavari, Montazeri and Mirzazadeh, 2011)
Timepoint [2] 332532 0
Immediate post intervention and 3 months post intervention
Secondary outcome [3] 332533 0
Post intervention attitude score, defined as the immediate and 3 months post intervention mean attitude score obtained from the answer given by the respondents in section E of the knowledge, attitude and FIT acceptability (KAFA) questionnaire divided by the maximum possible score of 120, and multiplied by 100 to get the percentage. It is measured using GLMM. The KAFA questionnaire contents were adapted from various studies and also designed specifically for this study. Section E was validated in a previous study elsewhere (Vernon, Myers and Tilley, 1997)
Timepoint [3] 332533 0
Immediate post intervention and 3 months post intervention
Secondary outcome [4] 332534 0
Post intervention acceptability score, defined as the immediate and 3 months post intervention mean acceptability score obtained from the answer given by the respondents in section F of the knowledge, attitude and FIT acceptability (KAFA) questionnaire divided by the maximum possible score of 100, and multiplied by 100 to get the percentage. It is measured using GLMM. The KAFA questionnaire contents were adapted from various studies and also designed specifically for this study. Section F was designed for this study and was content-validated by public health medicine specialists in this research team,
Timepoint [4] 332534 0
Immediate post intervention and 3 months post intervention

Eligibility
Key inclusion criteria
1. Organizations with SOCSO-insured workers in Kuantan, Pahang
2. Malaysian citizen aged 18 years and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have ever been diagnosed with CRC before the date data collection starts

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization concealment process using sealed, opaque envelope will be done by enumerator to reduce bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified block randomization method will be used. Organizations will be stratified into size of organization, which are small (5 to 74 workers), medium (74 to 199 workers) and large (200 or more workers) organizations. This is done to control possible influence from covariates towards the outcome such as organizational health policy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size estimation is based on Sample Size Determination in Health Studies by Lemeshow and Lwanga (1990). Two population proportions formula is used due to it being analytical in nature and comparing 2 groups for hypothesis testing. The effect of the
intervention is proposed to increase the uptake by equal or more
than 30% compared to the control group. Given the power of
80% to detect a true difference with 95% confidence, the sample
size required after adjusting for the clustered design effect is 380
participants, with 190 participants in each arm coming from 6
intervention groups and 6 control groups

Data will be analyzed using Statistical Package for Social Science (SPSS) version 22.0. Descriptive statistic using continuous data will be analyzed either by mean or median, depending on normality, while categorical data analyzed using frequency (n) and percentage (%). Cluster level analysis will be utilized to cater for the clustering effect. Multivariate analysis on FIT uptake, knowledge score, perception score and acceptability score will be done using generalized linear mixed model. This will cater for both fixed effect and random effects as well as the clustering effect. On the other hand, trend analysis using repeated measure ANOVA will be done to measure FIT uptake from immediate post intervention to 3 months follow-up after the post-intervention data collection. Intention-to-treat (ITT) and per protocol (PP) analysis will be utilized as a component of sensitivity analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment outside Australia
Country [1] 8716 0
Malaysia
State/province [1] 8716 0
Kuantan, Pahang

Funding & Sponsors
Funding source category [1] 295851 0
University
Name [1] 295851 0
International Islamic University Malaysia
Country [1] 295851 0
Malaysia
Funding source category [2] 296107 0
University
Name [2] 296107 0
Universiti Putra Malaysia
Country [2] 296107 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia
Address
Research Management Centre,
Tower II UPM-MTDC Technology Centre,
Universiti Putra Malaysia,
43400 UPM Serdang,
Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 294721 0
None
Name [1] 294721 0
Address [1] 294721 0
Country [1] 294721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297135 0
UPM Ethics Committee for Research Involving Human Subjects
Ethics committee address [1] 297135 0
Research Management Centre,
Tower II UPM-MTDC Technology Centre,
Universiti Putra Malaysia,
43400 UPM Serdang,
Selangor, Malaysia.
Ethics committee country [1] 297135 0
Malaysia
Date submitted for ethics approval [1] 297135 0
18/08/2016
Approval date [1] 297135 0
16/12/2016
Ethics approval number [1] 297135 0
FPSK(EXP16)P148

Summary
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.
Trial website
Trial related presentations / publications
Edre MA, Hayati KS, Salmiah MS, Sharifah Norkhadijah SI and
Azmi MN (2017) A Cluster Randomized Trial Study Protocol on Effectiveness
of Health Education Module (HAEMOD) on Colorectal Cancer
Screening Uptake among Workers in Kuantan District, Pahang State,
Malaysia. BAOJ Cancer Res Ther 3: 032.
Public notes

Contacts
Principal investigator
Name 73090 0
Dr Edre Mohammad Aidid
Address 73090 0
Department of Community Medicine,
Kulliyyah of Medicine,
International Islamic University Malaysia,
Bandar Indera Mahkota Campus,
Jalan Sultan Ahmad Shah,
25200 Kuantan, Pahang Darul Makmur, Malaysia.
Country 73090 0
Malaysia
Phone 73090 0
+6095704592
Fax 73090 0
Email 73090 0
[email protected]
Contact person for public queries
Name 73091 0
Hayati Kadir Shahar
Address 73091 0
Department of Community Health,
Faculty of Medicine And Health Sciences,
Universiti Putra Malaysia,
43400 Serdang,
Selangor, Malaysia.
Country 73091 0
Malaysia
Phone 73091 0
+60389472424
Fax 73091 0
+60389450151
Email 73091 0
[email protected]
Contact person for scientific queries
Name 73092 0
Edre Mohammad Aidid
Address 73092 0
Department of Community Medicine,
Kulliyyah of Medicine,
International Islamic University Malaysia,
Bandar Indera Mahkota Campus,
Jalan Sultan Ahmad Shah,
25200 Kuantan, Pahang Darul Makmur, Malaysia.
Country 73092 0
Malaysia
Phone 73092 0
+6095704592
Fax 73092 0
Email 73092 0
[email protected]

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