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Trial registered on ANZCTR


Registration number
ACTRN12616000831482
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
23/06/2016
Date last updated
23/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing breast self examination among female students by using different methods of health education
Scientific title
Effect of Health Educational Strategies toward breast self-examination practice among female public university students in Klang Valley, Malaysia
Secondary ID [1] 289301 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 298889 0
Condition category
Condition code
Public Health 298967 298967 0 0
Health promotion/education
Cancer 298968 298968 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1 (knowledge and skill based strategy): used an educational module on breast health awareness which was developed based on American Cancer Society and Clinical Guidelines of Malaysia for breast cancer screening. It compromised of four sections: breast health awareness; normal breast; breast cancer; other screening methods. It delivered to all participate in this group by one-hour lecture which covered all contents of the “educational module on breast health awareness” in the form of slide presentation. It was presented by the main researcher with background of nursing and four years experience in breast health training. Educational module is followed immediately by the skill based training. This group
received another one-hour training on breast silicon model by registered nursing to demonstrate the search strategy (concentric circle or line method) and palpation technique (how the fingers are positioned and press against the skin surface) when examining the breasts. Following the instructor’s demonstration, each student was asked to duplicate the examination on the breast model and asked their questions. Training was continued until the students perform the examination correctly and indicate that she was confident in her ability to do the examination.

Arm2 (Knowledge-based strategy): In this strategy researcher used the same educational module which is used in arm 1 (knowledge-based and skill-based strategies). The educational module delivered to all the participants of this group on the day of the workshops. Power-point presentation covering the four sections of this module. It was presented by the main researcher with backgraound of nursing and four years experience in breast bealth training.

Arm 3 (Skill-based Strategy): The lab training section included BSE practice on a silicon breast model. This lab training was the same with lab training section on arm 1 (knowledge-based and skill-based strategy).
Intervention code [1] 294854 0
Behaviour
Comparator / control treatment
The control group participants did not receive any education during the study period but the usual treatment from the health centers of each university or any campaign for breast cancer provided by the Ministry of Health Malaysia. However, they received the educational module and a training of the BSE practice on a silicon breast model after the data collection time ended in a 12 months time.
Control group
Active

Outcomes
Primary outcome [1] 298446 0
Breast self-examination practice. It was assessed through the questions that designed specifically for this study.
Breast self examination (BSE) practice was assessed by self-reported responses to two questions which included whether they had ever carried out BSE (yes/no) and the frequency of doing BSE (“once a month”, “occasionally”, “others” and “never”). A woman who performed BSE once a month was categorised as practicing “regular BSE” while a woman who performed occasionally or others was categorised as practicing “irregular BSE”.
Timepoint [1] 298446 0
six and twelve months after intervention
Secondary outcome [1] 324145 0
Health Belief model sub scales(HBM) which was assessed via validated standard questionnaire of the Champion’s Health Belief Model Scale to measure health beliefs and BSE (Champion, 1993).

Champion, V.L. (1993). Instrument refinement for breast cancer screening behaviors. Nursing Research, 42(3),138-143.
Timepoint [1] 324145 0
Six and twelve months after intervention
Secondary outcome [2] 324691 0
knowledge of breast cancer
Participants’ breast cancer knowledge was assessed using 25 items which included general facts of breast cancer (5 items), knowledge of symptoms of breast cancer (6 items), risk factors (10 items), as well as CBE and mammography (4 items). The items were derived from the literature and specifically developed for this study. Responses were measured using the nominal scale of “True”, “False” and “I do not know”.
Timepoint [2] 324691 0
six and twelve months after intervention
Secondary outcome [3] 324692 0
Knowledge of breast self-examination (BSE)
Participants knowledge of BSE was assessed using 10 items . The items were derived from the literature and developed for this study. Responses were measured using the nominal scale of “True”, “False” and “I do not know”.
Timepoint [3] 324692 0
six and twelve months after intervention

Eligibility
Key inclusion criteria
1. Malaysian citizen
2. 20 years old and above
3. Female undergraduate students
Minimum age
20 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
I. Students who are pregnant and breast feeding
II. No Medic or Health Faculties involved
III. Students in final semester of their study
IV. Students who refused to be involved in study

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A multi-stage sampling method was used and the eligible participants were assigned randomly in control group and intervention groups by using randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
1. The data was analyzed by using Statistical Package for Social Science (SPSS) package
version 19.0.
2. One-Way ANOVA was used to determine the differences in the means of continuous data between control and three intervention groups. The chi-square test was used to determine the association for categorical data.
3. Two-way repeated measure ANOVA (GLM) was performed to test whether there is
significant difference in the knowledge, belief means score between study groups at
different times over the period of study.
4. The Cochran’s Q test was used to assess the difference in proportion of breast self-examination practices (BSE) within study groups.

The sample size of this study was estimated by using the Rosner’ formula for testing the difference in proportions between two samples [1]. In order to achieve 80% power to detect a group difference of 13% [2] with a two-sided 5% significance level, 165 female students in each arm were required. With considering 20% drop out of the subjects during the study, the final sample size calculation was 792 with 198 subjects in each intervention and control groups.

[1].Rosner B. 920110. Fundamentals of Biostatistics. 7th ed. California, Thomson.
[2]. Parsa P. (2008). Effects of educational interventions pertaining to knowledge, beliefs, practices on breast cancer screening behavior among teachers in Selangor, Malaysia [dissertation]. Universiti Putra Malaysia, Serdang, Malaysia.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7907 0
Malaysia
State/province [1] 7907 0
Klang Valley

Funding & Sponsors
Funding source category [1] 293685 0
University
Name [1] 293685 0
Universiti Putra Malaysia
Address [1] 293685 0
Universiti Putra Malaysia
43400, Serdang
Selangor Darul Ehsan, MALAYSIA
Country [1] 293685 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia (School of Graduate Studies)
Address
School of Graduate Studies
Zone 4, Off Jalan Stadium
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan, MALAYSIA

Country
Malaysia
Secondary sponsor category [1] 292629 0
None
Name [1] 292629 0
Address [1] 292629 0
Country [1] 292629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295124 0
Medical Research Ethics Committee of the Faculty of Medicine and Health Sciences, UPM
Ethics committee address [1] 295124 0
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Lorong Asam Jawa 1, Selangor, 43400 Serdang, Malaysia
Ethics committee country [1] 295124 0
Malaysia
Date submitted for ethics approval [1] 295124 0
01/10/2009
Approval date [1] 295124 0
21/04/2010
Ethics approval number [1] 295124 0
UPM/FPSK/PADS/T7-MJKEtikaPer/F01(JKK_NOV(09)12)

Summary
Brief summary
Breast cancer is the most common cancer and the second principal cause of cancer deaths among women worldwide as well as in Malaysia. Early detection of breast cancer can play an important role in reducing cancer morbidity and mortality. Mammography and clinical breast examination (CBE) are considered as screening methods for early detection of breast cancer. Practicing breast self-examination (BSE) could provide an opportunity for women to know how their breasts normally feel and notice any changes in their breast. Studies have shown that among younger women breast cancer tend to be more advanced stage and more aggressive than those affecting older women. The objective of this study was to comparing health educational strategies towards breast self-examination practice among female public universities’ students in Klang Valley.

A multi-stage random sampling was used for selection of participants. All female students those fulfill the inclusion criteria of the study were invited to participate in the study with informed consent form. A translated, reliable and valid tool adopted from Champion’s Health Belief Model was used to determine women’s perceptions on breast cancer and BSE. Three types of intervention strategies namely knowledge-based, knowledge-based and skill-based and skill-based strategies were implemented for this study. The strategies were supported by educational module, presentation, and demonstration on BSE practice on breast silicon model. The control group received all of the informational material and BSE practice after the completion of the study. To evaluate the effect of the intervention, data were collected at baseline, 6 months and 12 months after intervention in 3 intervention groups and control group. Descriptive and multivariate statistics were used for analysis the data using SPSS version 19.0.

Baseline data were collected from 792 female students in four groups. At 12- month follow assessment, data was collected from 183 (92.42%) in intervention group one, 186 (93.93%) in intervention group two, 189 (95.45%) in intervention group three and 184 (94.94%) in control group. The mean age of participants was 22 years with standard deviation 1.20 and majority of them were Malay (728, 91.9%), single (767, 96.8%). After intervention, there was a significant increase in the mean score of knowledge on breast cancer in intervention Group One (knowledge-based) (11.28-12.15, p-value less than or equal to 0.001), intervention Group Two (knowledge-based and skill-based strategy)(11.32-13.09, p-value less than or equal to 0.001) and intervention Group Three (skilled-based strategy)(11.05-11.52, p-value less than or equal to 0.008). Regarding knowledge of BSE, there was a significant increase in the mean score of knowledge BSE in intervention Group One (6.19-7.13, p-value less than or equal to 0.001), intervention Group Two (6.29-7.79, p-value less than or equal to 0.001) and intervention Group Three (6.01-6.70, p-value less than or equal to 0.001). Proportion of BSE practice was increased in intervention Group One (20.2%-21.9%, p-value less than or equal to 0.005), intervention Group Two (23.7%-30.1%, p-value less than or equal to 0.001) and intervention Group Three (18.0%- 24.3%, p-value less than or equal to 0.001), over the twelve months follow up in the intervention groups. Health Belief Model (HBM) constructs significantly differences for susceptibility, confidence and motivation in the intervention groups and control group (p-value less than or equal to 0.05). the logistic regression model showed that change in total knowledge score of breast cancer (OR=1.58), motivation (OR=1.47), susceptibility to breast cancer (OR=1.47) and seriousness of breast cancer (OR=1.28) were predictors of BSE practice after twelve months.

The results provide evidence for the effectiveness an educational strategies using a multi-component approaches in improving breast self-examination practice, knowledge of breast cancer and BSE and beliefs within young female students in Malaysia. This study suggests that the three interventions had impacts on knowledge, beliefs and BSE practice but there were no significant differences among them which should lead to recommendation that policy makers should adopt the cheapest and most feasible of the three intervention strategies.
Trial website
Trial related presentations / publications
1. Akhtari-Zavare, M., Latiffah A Latiff., Muhamad Hanafiah Juni., Irmi Zarina Ismail, Salmiah Md. Said. (2015). Knowledge of female undergraduate students on breast cancer and breast self-examination in Klang Valley, Malaysia. Asian Pacific J Cancer Prev, 16 (15), 6231-6235 .
2.Akhtari-Zavare, M., Latiffah A Latiff, Muhamad Hanafiah Juni, Salmiah Md Said, Irmi Zarina Ismail. (2015). Predictors affecting breast self-examination practice among undergraduate female students in Klang Valley, Malaysia. The Journal of Obstetrics and Gynecology Research. DOI:10.1111/jog.12819.
3. Akhtari-Zavare, M., Muhamad Hanafiah Juni., Irmi Zarina Ismail, Salmiah Md. Said., Latiffah A Latiff. (2015). Health Beliefs and Breast Self-Examination among Undergraduate Female Students in Public Universities in Klang Valley, Malaysia. Asian Pac J Cancer Prev, 16 (9), 4019-4023.
4. Akhtari-Zavare, M., Muhamad Hanafiah Juni, Salmiah Md Said, Irmi Zarina Ismail, Latiffah A Latiff. (2015). Barriers to breast self-examination practice among Malaysian female students: a cross sectional study. Springer Plus, 4:692. DOI 10.1186/s40064-015-1491-8
Public notes

Contacts
Principal investigator
Name 66174 0
Dr Mehrnoosh Akhtari-Zavare
Address 66174 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 66174 0
Malaysia
Phone 66174 0
+60 3 8947 1011
Fax 66174 0
+60 3 8947 2706
Email 66174 0
mehrnoos_zavare@upm.edu.my
Contact person for public queries
Name 66175 0
Dr Mehrnoosh Akhtari-Zavare
Address 66175 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 66175 0
Malaysia
Phone 66175 0
+60 3 8947 1011
Fax 66175 0
+60 3 8947 2706
Email 66175 0
mehrnoos_zavare@upm.edu.my
Contact person for scientific queries
Name 66176 0
Dr Mehrnoosh Akhtari-Zavare
Address 66176 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 66176 0
Malaysia
Phone 66176 0
+60 3 8947 1011
Fax 66176 0
+60 3 8947 2706
Email 66176 0
mehrnoos_zavare@upm.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary