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Prostate CancerNCT07878663

Developing and Validating Health Education Module for Prostate Cancer Prevention Behavior in Iraqi Male University Staff

A study testing Web Application Health Education Module in people with Prostate Cancer and Health Knowledge, Attitudes, Practice, run by Universiti Sains Malaysia at 1 site in Iraq.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Research Objectives To compare the effectiveness of the education modules on the knowledge, attitude, and practice of male university staffs towards prostate cancer prevention behaviors by comparing the pre- and post-test of Iraqi male university staffs' knowledge, attitude, and practice. Read more about this study

Who is it for?
Ages 40 years and older, men onlyHealthy volunteers can take part
What is being tested?
Web Application Health Education Module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteIraq
Study dates
20 Sep 2026to 20 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males at risk are 40 years of age and over.
  • The male who educational level primary school and above.
  • The male who gives informed consent and is willing to participate in the study.
  • Men who did not receive any health education program about prostate cancer.

Who cannot join

  • The male staff outside middle technical university.
  • The male who has prostate cancer.
  • The male who is critically illness.
  • Withdrawal criteria include males who are unable or unwilling to comply with the study requirements, failure to attend the meeting schedules, and have substantial changes in health conditions, such as developing new medical conditions, having serious adverse events, or any other conditions that could impact the study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed K Jawad, MSc contact

9647703194933

ahmed.kj@mtu.edu.iq

Dr. Wan N Arifin contact

+60 17-916 5743

wnarifin@usm.my

Iraq1 site
  • College or institute at the Middle Technical University

    Baghdad, Alhabebia, 10001

    Ahmed k Jawad, MSc, 9647703194933, ahmed.kj@mtu.edu.iq

    Dr. Wan N Arifin, PhD, +60 17-916 5743, wnarifin@usm.my

Other trials in Iraq

About this study

Official title: Effectiveness of a Novel Web Application Health Education Intervention in Enhancing Knowledge, Attitudes, and Practices to Promote Prostate Cancer Prevention Behaviors Among Male University Staff in Iraq

Research Objectives To compare the effectiveness of the education modules on the knowledge, attitude, and practice of male university staffs towards prostate cancer prevention behaviors by comparing the pre- and post-test of Iraqi male university staffs' knowledge, attitude, and practice.

Study population The research will proceed to be performed in the country of Iraq. Participants in the research will be male university staff members who are employed at Middle Technical University (MTU). This university contains 17 colleges and institutes, divided into five colleges and twelve institutes that are spread across four cities in Iraq.

Read more

Inclusion criteria

  1. Males at risk are 40 years of age and over.
  2. The male who educational level primary school and above.
  3. The male who gives informed consent and is willing to participate in the study.
  4. Men who did not receive any health education program about prostate cancer.

Exclusion criteria

  1. The male staff outside middle technical university.
  2. The male who has prostate cancer.
  3. The male who is critically illness.
  4. Withdrawal criteria include males who are unable or unwilling to comply with the study requirements, failure to attend the meeting schedules, and have substantial changes in health conditions, such as developing new medical conditions, having serious adverse events, or any other conditions that could impact the study results.

Study Design The study will be a Cluster Randomized Controlled Trial (Cluster RCT) study design among male university staff with a pre-test and post-test to evaluate the effectiveness of the intervention modules that will be used for the study in this phase. A control group will be chosen that has similar characteristics and functioning as the intervention group.

Sampling method The study will consist of selecting one college or institute out of 8 using a simple random sampling method, which will involve the classification of one college or institute for the intervention group and one for the control group. This will be done by utilizing a randomization process. The participants will be volunteers to participate in the study, and then the final selection of study participants will be determined by the specific inclusion criteria established for each group. The selection of participants will be contingent upon adherence to the predetermined sample size.

Read the detailed description

Background and Rationale Limited knowledge, attitudes, and unfavorable practices toward prostate cancer can delay early detection and the adoption of preventive behaviors among men at increased risk. Health education is a low-cost strategy to address these gaps, and web-based delivery allows working adults to access educational content at a time and place convenient to them. This trial will assess whether a structured, Arabic-language web-based health education module improves prostate cancer prevention knowledge, attitudes, and practices among male university staff in Iraq. In Iraq, PCa is the ninth most prevalent cancer, with 1313 cases (5.55%). It is the 4th most widespread tumor among males in the top 10, with 1313 cases (12.38%). The 2020 Annual Statistics Report of the Ministry of Health/Environment Iraq (MOH) classified prostate cancer as one of the top ten primary site cancer fatalities. It caused 3.3% of all cancer deaths and 6.5% of male deaths, ranking sixth among all malignancies.

Setting and Cluster Allocation The study will be conducted at Middle Technical University (MTU), Iraq, which comprises 17 colleges and institutes (5 colleges and 12 institutes) located in five cities. The unit of randomization is the college or institute (cluster). From 8 eligible colleges/institutes, two clusters will be selected using simple random sampling, and one will be randomly allocated to the intervention group and the other to the control group using randomization method, sealed-envelope lottery. Allocation will be performed by an independent person not involved in recruitment.

Within each allocated cluster, male staff will be invited to take part, and volunteers who meet the eligibility criteria will be enrolled consecutively until the required sample size of 80 participants per group is reached.

Sample Size Calculation The sample size was calculated using G*Power version 3.1.9.4 (F-tests family). Calculations were performed for repeated-measures ANOVA (between factors, within factors, and within-between interaction), and the largest resulting sample size was adopted. Parameters were a medium effect size (f = 0.25; Cohen, 1988), α = 0.05, power (1 - β) = 0.80, two groups, and two measurement points (pre-test and post-test). The minimum required sample size was 128 participants. Allowing for an anticipated 20% drop-out rate, the sample size was inflated to 160 (128 / 0.80), i.e., 80 participants per group.

Intervention The intervention group will receive a web-based health education module (HEM) on prostate cancer prevention behaviors, delivered in Arabic through a web application over 12 weeks. The first session, delivered through the intervention group's WhatsApp group, will introduce the study and provide instructions on accessing and using the web application. Subsequent sessions will deliver educational content covering promoting behaviors for prostate cancer prevention comprised of six topics, consisting of an introductory home page and five learning modules that address the anatomy and function of the prostate gland, prostate gland diseases, the causes and risk factors of prostate cancer, the methods used for the diagnosis and treatment of prostate cancer, and prostate cancer prevention measures. Various educational content, including an overview of the prostate gland and prostate cancer statistics, descriptions of benign prostatic hyperplasia and prostatitis, unmodifiable and modifiable risk factors, screening and confirmatory diagnostic tests, treatment modalities, and preventive behaviors and measures, was incorporated into the web application module.

WhatsApp will be used as the communication and follow-up platform for reminders, answering questions, and supporting use of the web application. The researcher will supervise delivery of the module, monitor participants' progress and use of the web application, and provide guidance to participants. The timing of contact sessions will be arranged flexibly with the approval of MTU and the participating colleges and institutes.

Control Group Participants in the control group will not receive the web-based health education module during the 12-week study period and will continue with their usual activities.

Prevention of Contamination Because randomization occurs at the college/institute level, participants in the intervention and control groups will work at different sites. Where possible, clusters located in different geographic areas will be selected, reducing the likelihood that participants in the two groups interact or share intervention materials. Separate WhatsApp groups will be created for each study group, and access to the web application will be restricted to intervention group participants.

Data Collection Procedures Data will be collected using a structured, self-administered questionnaire in Arabic, delivered through Google Forms and distributed via each group's WhatsApp group. The questionnaire was developed by authors. Both groups will complete the questionnaire at baseline (before the intervention) and immediately after completion of the 12-week intervention period, using the same instrument at both time points.

Participants may be withdrawn if they are unable or unwilling to comply with the study requirements, fail to attend scheduled sessions, or experience substantial changes in health conditions that could affect the study results.

Statistical Analysis Data will be analyzed using IBM SPSS Statistics version 26. Baseline characteristics of the two groups will be compared using appropriate tests (e.g., independent t-test or chi-square test). Changes in knowledge, attitude, and practice scores between the intervention and control groups from pre-test to post-test will be examined using mixed (within-between) repeated-measures ANOVA, consistent with the sample size calculation. A p-value < 0.05 will be considered statistically significant. Scores will be analyzed as continuous and categorical variables. Raw scores are converted to percentages (0-100%), where ≥70% is classified as Good Knowledge, Positive Attitude, and Positive Prevention Practices, and <70% as Poor/Negative. Based on this 70% threshold, the raw score cut-offs are: Knowledge ≥25, Attitude ≥161, and Practices ≥95. Higher scores indicate better outcomes.

Being tested
Web Application Health Education Module
Keywords
Prostate cancer prevention, Health education, Web application, Health education module, Knowledge, attitudes, and practices, Male university staff
Medical subject headings
Prostatic Neoplasms, Behavior, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web Application Health Education ModuleBehavioural

    Also called Web Application

    Participants in this arm will receive a web-based health education intervention designed to promote prostate cancer prevention behaviors. The module covers evidence-based topics, including six topics, consisting of an introductory home page and five learning modules that address the anatomy and function of the prostate gland, prostate gland diseases, the causes and risk factors of prostate cancer, the methods used for the diagnosis and treatment of prostate cancer, and prostate cancer prevention measures. The web application delivers interactive content through educational videos and text summaries. This intervention differs from standard care by providing tailored, interactive digital education aimed at behavioral change rather than standard printed informational materials.

Study groups in NCT07878663
Study groupRoleWhat they receive
Intervention groupOtherData collection for a Cluster Randomized Controlled Trial (Cluster RCT) Participants in this group will complete a pre-test using a self-administered questionnaire via Google Forms. Subsequently, they will receive a web application health education module related to prostate cancer prevention behaviors, delivered via a WhatsApp group. A post-assessment survey will be administered at 3 months post-intervention.
Receives: Behavioral: Web Application Health Education Module
Control GroupOtherParticipants in this group will complete a pre-test using a self-administered questionnaire via Google Forms. They will NOT receive the web application health education module. A post-assessment survey will be administered at 3 months post-intervention.
Receives: Behavioral: Web Application Health Education Module

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of a Novel Web Application Health Education Intervention in Enhancing Knowledge, Attitudes, and Practices to Promote Prostate Cancer Prevention Behaviors among Male University Staff in Iraq

    The web application health education module (HEM) will be provided to male university staff in accordance with the participants' informed consent and the relevant institutional requirements. The intervention group will receive a web-based health education programme focused on prostate cancer prevention behaviors. The intervention will be delivered through the web application, while WhatsApp will be used as a communication and follow-up platform.

    The intervention will be provided to male university staff who voluntarily choose to participate in the study and provide informed consent by signing the consent form. Participants in the intervention group will be closely monitored and supported throughout the intervention period. The researcher will supervise the delivery of the module and provide the necessary guidance and feedback to the facilitators to ensure the effective use of the web application and adherence to the programme.

    Measured: . The post-assessment survey will be administered to both the intervention and control groups immediately after completion of the 12-week intervention period.

  2. Effectiveness of a Novel Web Application Health Education Intervention in Enhancing Knowledge, Attitudes, and Practices to Promote Prostate Cancer Prevention Behaviors among Male University Staff in Iraq

    The instrument consists of Knowledge (36 items, 0-36 points), Attitude (46 items, 1-5 Likert scale, 46-230 points), and Practices (34 items, 0-4 frequency scale, 0-136 points).

    Scores will be analyzed as continuous and categorical variables. Raw scores are converted to percentages (0-100%), where ≥70% is classified as Good Knowledge, Positive Attitude, and Positive Prevention Practices, and <70% as Poor/Negative. Based on this 70% threshold, the raw score cut-offs are: Knowledge ≥25, Attitude ≥161, and Practices ≥95. Higher scores indicate better outcomes.

    Measured: Baseline and 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start20 Sep 2026 (estimated)
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Health education module evaluation The web application health education module (HEM) will be provided to male university staff in accordance with the participants' informed consent and the relevant institutional requirements. The intervention group will receive a web-based health education programme focused on prostate cancer prevention behaviors. The intervention will be delivered through the web application, while WhatsApp will be used as a communication and follow-up platform. The intervention will be provided to male university staff who voluntarily choose to participate in the study and provide informed consent by signing the consent form. Participants in the intervention group will be closely monitored and supported throughout the intervention period. The researcher will supervise the delivery of the module and provide the necessary guidance and feedback to the facilitators to ensure the effective use of the web application and adherence to the programme.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878663
Sponsor's protocol ID
USM/JEPeM/KK/24020193
Status last verified
Oct 2026
First submitted
29 Sep 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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