Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
1/01/2011
Date of last participant enrolment
Anticipated
Actual
30/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
792
Accrual to date
Final
742
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 66175 0
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
[email protected]
Contact person for scientific queries
Name 66176 0
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseResult of randomized control trial to increase breast health awareness among young females in Malaysia.2016https://dx.doi.org/10.1186/s12889-016-3414-1
N.B. These documents automatically identified may not have been verified by the study sponsor.