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Trial registered on ANZCTR

Registration number

ACTRN12622001445763

Ethics application status

Approved

Date submitted

29/10/2022

Date registered

11/11/2022

Date last updated

11/11/2022

Date data sharing statement initially provided

11/11/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effectiveness of An Educational Intervention On Knowledge, Attitude and Practice Regarding Cervical Cancer Screening Among Yemeni Immigrant Women In Klang Valley, Malaysia: A Study Protocol for a Randomized Controlled Trial

Scientific title

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cervical cancer

Condition category

Condition code

Public Health

Health promotion/education

Cancer

Cervical (cervix)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is comprised of an online health education on cervical cancer and screening via zoom sessions for two weeks. This intervention is grounded in the Health Belief Model (HBM) and developed based on the American cancer Society, American Congress of Obstetricians and Gynaecologists, and the results of the systematic review in order to know the best method to deliver the intervention. This program also is prepared and designed to fill up the gap of cervical cancer and Pap smear knowledge and to modify beliefs related to cervical cancer screening. Providing this information may promote cervical screening practice.
The education on cervical cancer will focus also on general information on the anatomy and physiology of a normal cervix in order for the participants to have a clear understanding of the topic, cause, predisposing factors, signs and symptoms, complications and methods of prevention. Regarding cervical cancer screening, participants will be introduced to where they can go for testing, persons who carry out the test and the part of the body needed for the test. The benefits of cervical cancer screening and the perceived barriers to screening will be addressed.
The educational intervention involves a 30-60 minute session for one-day. One session will be carried out each week. The study researcher will conduct the session for all the intervention group (55 participants). The educational materials (PowerPoints and videos) will be shared with the intervention group before giving the educational intervention. The zoom session will be recorded and shared with participants to enable them to remember the information and the discussion with them. To avoid contamination with the control group, the intervention group will be asked in the consent form to not share any educational information or materials with others till the end of the study.
Furthermore, all participants in the control group will receive education on healthy eating (55 participants) during the study period. However, they will be given the same educational materials at the end of the study.
Content of the intervention:
-- Anatomy of the cervix
- Functions of cervix
- What is cervical cancer
- Cervical cancer risk factors
- Signs and symptoms of cervical cancer
- Pre-cancers and types of cervical cancer
- Cervical cancer stages
-What is the screening, types, time and benefit of doing the screening, source of knowledge about screening
-Pap smear test

To support the fidelity of the educational intervention, some strategies will be used. These include the strategy for preserving the consistency of the intervention delivery and for encouraging participants’ adherence to the intervention. To maintain consistency in the intervention delivery, the educational intervention is implemented independently by the same researcher. The researcher will commit to adopting a single educational intervention protocol to ensure a standard delivery across the respective groups. Other possible means of enhancing intervention fidelity include the monthly short reminder text messages. These are mainly employed to encourage participants, remind them of the importance of cervical cancer screening practice and to reinforce the intended messages.
Participants must only be Yemeni immigrant women and who did not have a Pap smear test in the previous three years.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

Participants in the control group will receive education on healthy eating during the study period. However, they will be given the same educational materials at the end of the study.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome variables in the present study is the practice of cervical cancer screening.
The data will be collected for this outcome via a predesigned online questionnaire. The questionnaire was composed according to the findings from a validated published study that were conducted in South Carolina, USA and city of Yaounde´, Cameroon. Furthermore, CHBM components will be added to the questionnaire after obtaining permission from the copyright owner (Kemboi, 2018; Mcdonell & Robinson, 2011).

Timepoint [1]

3 months from the intervention commencement.

Secondary outcome [1]

i) Knowledge of cervical cancer and screening
The data will be collected for this outcome via a predesigned online questionnaire. The questionnaire was composed according to the findings from a validated published study that were conducted in South Carolina, USA and city of Yaounde´, Cameroon. Furthermore, CHBM components will be added to the questionnaire after obtaining permission from the copyright owner (Kemboi, 2018; Mcdonell & Robinson, 2011).

Timepoint [1]

baseline, immediately after intervention, 3 months post intervention

Secondary outcome [2]

ii) Attitude towards cervical cancer screening
The data will be collected for this outcome via a predesigned online questionnaire. The questionnaire was composed according to the findings from a validated published study that were conducted in South Carolina, USA and city of Yaounde´, Cameroon. Furthermore, CHBM components will be added to the questionnaire after obtaining permission from the copyright owner (Kemboi, 2018; Mcdonell & Robinson, 2011).

Timepoint [2]

baseline, immediately after intervention, and 3 months post intervention

Eligibility

Key inclusion criteria

(1) Participants must only be Yemeni immigrant women;
(2) Who did not have a Pap smear test in the previous three years;
(3) Participants are aged 20 years old or older;
(4) Women who are married or have been married previously.
(5) Who have smart phone and WhatsApp application.

Minimum age

20 Years

Maximum age

65 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

(1) Who have been diagnosed with gynaecological cancer;
(2) Who have undergone a hysterectomy;

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2023

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Klang Valley

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Sarah Ahmed Al-Oseely

Address

-E-15-05 One South condominium, Jalan OS
Selangor
43300
---------
-Department of Community Health, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Jalan Universiti 1, 43400 Serdang, Selangor, Malaysia.

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Jawatankuasa Etika Universiti Untuk Penyelidikan Melibatkan Manusia (JKEUPM) at Universiti Putra Malaysia

Ethics committee address [1]

Jalan Universiti 1
Serdang
Selangor
43400
Malaysia

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

Approval date [1]

27/12/2021

Ethics approval number [1]

[Ref No: UPM/TNCPI/RMC/JKEUPM/1.4.18.2 (JKEUPM)]

Summary

Brief summary

This study aims to create and assess the efficacy of an educational intervention on knowledge, attitude, and practice of cervical screening among Yemeni immigrant women in Klang Valley, Malaysia. The Health Belief Model will serve as the intervention's direction.

Trial website

Trial related presentations / publications

Public notes

Face and content validity will be checked and assessed by professional expert panellists from the Community Health Department at the Faculty of Medicine and Health Sciences, Universiti Putra Malaysia. The experts approved the educational material as efficient with respect to the study objectives. The translated questionnaire will be pre-tested among 60 Yemeni women who are not of the participants in the study to get a glimpse of possible pitfalls that one must anticipate and deal with. To measure the reliability, the questionnaire will be given to 60 Yemeni women. The internal consistency of the rating scales will be tested by Cronbach’s alpha coefficient to measure reliability. Cronbach’s Alpha greater than 0.70 will present good reliability, and items of a variable have a total correlation coefficient being bigger than 0.30 are valid.

Contacts

Principal investigator

Name

Dr Sarah Ahmed Al-Oseely

Address

Country

Malaysia

Phone

+601137012569

Fax

dr.sarahoseely@gmail.com

Contact person for public queries

Name

Dr Sarah Al-Oseely

Address

Country

Malaysia

Phone

+601137012569

Fax

dr.sarahoseely@gmail.com

Contact person for scientific queries

Name

Dr Sarah Al-Oseely

Address

Country

Malaysia

Phone

+601137012569

Fax

dr.sarahoseely@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17504	Ethical approval					384912-(Uploaded-29-10-2022-07-16-05)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically