Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000173291
Ethics application status
Approved
Date submitted
19/08/2017
Date registered
2/02/2018
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of an education program on increasing early detection tests, knowledge, and beliefs related to breast cancer among Yemeni female school teachers in Klang Valley, Malaysia.
Scientific title
Effectiveness of an Educational Method on Breast Cancer Screening Practices, Knowledge, and Beliefs among Yemeni Female School Teachers in Klang Valley, Malaysia
Secondary ID [1] 292955 0
Nil known
Universal Trial Number (UTN)
U1111-1193-4480
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 302195 0
Condition category
Condition code
Public Health 304604 304604 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief name:
An educational program on breast cancer screening

2. The rationale of the educational program:
Many educational programs that were grounded based on the health belief model have shown improvement in the practice of breast cancer early detection behaviors among participants.

3. Materials used in the educational program:
The intervention group received a behavior change educational program developed based on American Cancer Society (2015), American Congress of Obstetricians and Gynecologists (2015), and International Agency for Research on Cancer (IARC) (2008). The educational program package includes 90 minutes, which composed of:
i) The power-point presentation last for 60 minutes, presented along with: five minutes short film about breast self-examination (BSE) performance, and another five minutes short film testimony for one of the breast cancer survivor.
ii) The training session was performed within thirty minutes that includes the practice of BSE on a silicon breast model with multiple implanted lumps.
iii) A dissemination of a booklet, a CD copy of the five minutes short film about BSE performance, and a breast cancer logo sticker.
iv) All participants in the intervention group will continue to receive short reminder text messages for 6 months.

4. Describe procedure:
i) 60 minutes Power-point presentation was implemented by the researcher, and presented along with five minutes short film about BSE performance, and another five minutes short film testimony for one of the breast cancer survivor. That addressed general information of anatomy and physiology of a normal breast, breast cancer knowledge, learning about the different methods of breast cancer screening, and the importance of breast health awareness.
ii) A training session that was performed within thirty minutes, which included the practice of BSE on a silicon breast model with multiple implanted lumps. During this section, teachers learned search strategy, palpation technique and signs of breast cancer that should be used when examining the breasts. Following this, the participants were asked to practice on the model and look for any lumps and abnormalities.
iii) At the end of the educational program, there was a dissemination of a booklet containing all the information that was delivered in the education program, a CD copy of the five minutes short film about BSE performance, and a breast cancer logo sticker to be hanged in the participants mirrors to remind them of the importance of breast cancer screening practices, monthly BSE performance, and to reinforce the messages.
iv) All participants in the intervention group will continue to receive short reminder text messages for 6 months. The key messages addressed recommendations about breast cancer screening behaviors to encourage participants of practicing breast cancer screening behaviors.

5. Who provided:
Only the study researcher delivered the educational program. Selection criteria for the researcher include receiving and supervision one day of training on BSE performance skills specific to the trial from an experienced medical doctor, and a master certificate of community health science.
For the training session, the procedure is simple, the researcher taught the participants BSE performance skills on a silicon breast model with multiple implanted lumps, then all participants involved in the study completed the training session by independently practice the procedure on the model.

6. How: Describe the modes of delivery:
Study researcher visited each of the study sites, then the education program was delivered through power point presentation and training sessions that held one time in each of the study clusters, and facilitated in groups of 18, then participants have been receiving short reminder text messages for 6 months aimed at reminding and giving them motivation to practice of early detection of breast cancer.

7. Where: Describe the type(s) of location(s)
Teachers were recruited from each school where the educational program was delivered.

8. When and how much: Describe the number of times the intervention was delivered and over what period of time.
The power point presentation of the educational program was delivered over 60 min, followed by the training session that was delivered over 30 min. Then, teachers have been receiving short reminder text message once a month for six months.

9. How well (planned): If intervention adherence or fidelity was assessed
The educational program package session was delivered independently in each of study cluster; the researcher was adhered to a single educational program protocol to ensure standardized delivery across schools. Researcher in the study sites was trained initially on BSE performance skills. BSE training delivery was planned by the researcher and rehearsed using role-play with the participants. In addition, the researcher acted as an observer during the training sessions in each school and provided feedback to participants. Adherence to the educational program was assessed by means of the self-reported questionnaire and the BSE proficiency rating skill collected during follow-up meetings to ensure rigorous adherence to the educational program throughout the duration of the trial. Data were categorized as no practice performed or yes practice performed, and check marks were given for BSE skills performed. Skills not performed or performed incorrectly are left blank.
A possible means of adhering fidelity is the monthly short reminder text messages to encourage them and to answer any inquiries, and the using of the breast cancer logo sticker to be hanged in the participants' mirrors can remind them of the importance of breast cancer screening practices, monthly BSE performance, and to reinforce the messages.
Intervention code [1] 298612 0
Prevention
Comparator / control treatment
1. Brief name:
An educational program on dengue fever

2. The rationale of the educational program:
Many educational programs have shown improvement in dengue fever prevention behaviors among participants.

3. Materials used in the educational program:
The control group received an educational program includes 60 minutes, which composed of:
i) Power-point presentation lasted for 60 minutes
ii) A dissemination of a booklet
iii) All participants in the control group will continue to receive short reminder text messages for 6 months.

4. Describe procedure:
i) 60 minutes Power-point presentation with classroom discussions was implemented by the researcher. That addressed general information of dengue fever, dengue fever knowledge, learning about methods of dengue fever prevention.
iii) At the end of the educational program, there was a dissemination of a booklet containing all the information that was delivered in the education program.
iv) All participants in the control group will continue to receive short reminder text messages for 6 months. The key messages addressed recommendations about dengue fever prevention behaviors to encourage participants.

5. Who provided:
Only the study researcher was delivered the educational program. Selection criteria for the researcher include having a master certificate of community health science.

6. How: Describe the modes of delivery:
Study researcher visited each of the study sites, then the education program delivered through power point presentation that held one time in each of the study clusters and facilitated in groups of 18, then participants continue to receive short reminder text messages for 6 months aimed at reminding and giving them motivation.

7. Where: Describe the type(s) of location(s)
Teachers were recruited from each school where the educational program was delivered.

8. When and how much: Describe the number of times the intervention was delivered and over what period of time.
A power point presentation of the educational program was delivered over 60 min. Then, teachers will continue to receive short reminder text message once a month for six months

9. How well (planned): If intervention adherence or fidelity was assessed, describe
how and by whom, and if any strategies were used to maintain or improve fidelity, describe them

The educational program package session was delivered independently in each of study cluster; the researcher was adhered to a single educational program protocol to ensure standardized delivery across schools.



Control group
Active

Outcomes
Primary outcome [1] 303105 0
Proportion of participants who perform breast self-examination regularly and proficiently.
Frequency is evaluated by performing breast self-examination monthly.
Proficiency is evaluated by asking the participant to perform the breast exam on a breast model. Scoring is achieved using the rating scale. Then checkmarks will be given for skill performed, skills not performed or performed wrongly will be left blank. the dichotomous items will be given values of +1 for skill performed or 0 for skill not performed, and total raw scores range from 0 to 23 with higher scores demonstrate better proficiency. Then percentage scores will be calculated by dividing participant raw score by maximum raw score (23) and multiplying the result by 100. Then the proportion of skills in the breast self-examination domain that participants have mastered is representing by this percentage.
Timepoint [1] 303105 0
Baseline, 1 month post intervention commencement, three months after intervention commencement, and six months after intervention commencement (primary timepoint).
Primary outcome [2] 303830 0
Proportion of participants who attend a radiology clinic for screening mammography and ultrasound, as assessed by questionnaire designed specifically for this study.
Timepoint [2] 303830 0
Baseline, 1 month post intervention commencement, three months after intervention commencement, and six months after intervention commencement (primary timepoint).
Primary outcome [3] 303831 0
Proportion of participants who attend a clinic for screening clinical breast examination, as assessed by questionnaire designed specifically for this study.
Timepoint [3] 303831 0
Baseline, 1 month post intervention commencement, three months after intervention commencement, and six months after intervention commencement (primary timepoint).
Secondary outcome [1] 337893 0
Knowledge level of breast cancer symptoms, risk factors, and breast health awareness using a questionnaire that was designed specifically for the study purpose.
Timepoint [1] 337893 0
Baseline, 1 month post intervention commencement, and at 3 and 6 months after intervention commencement
Secondary outcome [2] 337894 0
Knowledge level of breast cancer mammography, clinical breast examination, and ultrasound using a questionnaire that was designed specifically for the study purpose.
Timepoint [2] 337894 0
Baseline, 1 month post intervention commencement, and at 3 and 6 months after intervention commencement
Secondary outcome [3] 337895 0
Breast cancer beliefs (perceived susceptibility, perceived seriousness, perceived benefits, perceived barriers, Confidence, health motivation level) using health belief model questionnaire.
Timepoint [3] 337895 0
Baseline, 1 month post intervention commencement, and at 3 and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria for schools
The inclusion criteria for schools are as below:
1. Primary and secondary Arabic schools
2. Schools located in Klang Valley
3. Schools who agree to participate in the study

Inclusion Criteria for teachers
The inclusion criteria for teachers are as below:
1. Yemeni female school teachers who are attending selected primary and secondary Arabic schools
2. Aged at 20 years old age and above
3. Teachers who sign consent form to participate in the study
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for schools
The exclusion criteria for schools are as below:
1. Arabic schools who do not have Yemeni female teachers
2. Non-Arabic schools

Exclusion Criteria for teachers
The exclusion criteria for teachers are as below:
1. Teachers who will retire during the study.
2. Teachers who have diagnosed with breast cancer.
3. Teachers who are pregnant or lactating

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence will be generated following simple randomization procedures (computerized random numbers)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this study, the total sample size required was calculated by applying the formula for difference between two proportions (Lemesho, 1990), as follows:
n=49
Additional adjustments for the sample size calculation
Adjust for two arms 49*2=98
Adjust for attrition rate 98/0.80=122
Adjust for expected proportion eligible 122/0.90= 136
Design effect = 1+(M-1) ICC
Estimated number of teachers= 250
Cluster size= 250/13=19
Design effect= 1+(19-1)*0.02 = 1.36
= 136*1.36=184
Therefore, the total sample size required is 184 participants
Number of clusters (schools) = 184/19 = 10
Analysis: Predictive Analytics Software (PASW) will be used to analyze the data. The alpha level of significance will be set at a value of 0.05. Statistical analyses included descriptive statistics of the sample, socio-demographic characteristics as well as respondents’ breast cancer screening knowledge, beliefs, and practices. MANCOVA will be used to compare knowledge and beliefs means score across variables while controlling for confounding variables. The Cochran’s Q test will be applied to determine the difference in the proportion of breast cancer screening practices (BSE, CBE, mammography, and ultrasound breast examination) within study groups. Generalized estimation equation will be used to assess the impact of condition (intervention, control) across Time 1, Time 2 and Time 3 on outcome variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
Actual
3/05/2017
Date of last data collection
Anticipated
Actual
3/11/2017
Sample size
Target
184
Accrual to date
Final
184
Recruitment outside Australia
Country [1] 9149 0
Malaysia
State/province [1] 9149 0
Selangor

Funding & Sponsors
Funding source category [1] 295709 0
Self funded/Unfunded
Name [1] 295709 0
Sarah Noman
Country [1] 295709 0
Malaysia
Primary sponsor type
Individual
Name
Sarah Noman
Address
Community Health Department,
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 296692 0
None
Name [1] 296692 0
Address [1] 296692 0
Country [1] 296692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297013 0
ETHICS Committee for Research involving Human Subjects, Universiti Putra Malaysia
Ethics committee address [1] 297013 0
Ethics committee country [1] 297013 0
Malaysia
Date submitted for ethics approval [1] 297013 0
14/11/2016
Approval date [1] 297013 0
28/11/2016
Ethics approval number [1] 297013 0
FPSK(EXP16)P151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72718 0
Miss Sarah Noman Abdulrahman
Address 72718 0
Community Health Department,
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 72718 0
Malaysia
Phone 72718 0
+601111781929
Fax 72718 0
Email 72718 0
[email protected]
Contact person for public queries
Name 72719 0
Hejar Binti Abdul Rahman
Address 72719 0
Community Health Department,
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 72719 0
Malaysia
Phone 72719 0
+60122362351
Fax 72719 0
+60389450151
Email 72719 0
[email protected]
Contact person for scientific queries
Name 72720 0
Sarah Noman Abdulrahman
Address 72720 0
Community Health Department,
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 72720 0
Malaysia
Phone 72720 0
+601111781929
Fax 72720 0
Email 72720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
due to the rule of the Human Ethics Committee


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
Dimensions AIEffectiveness of an Educational Intervention of Breast Cancer Screening Practices Uptake, Knowledge, and Beliefs among Yemeni Female School Teachers in Klang Valley, Malaysia: A Study Protocol for a Cluster-Randomized Controlled Trial2020https://doi.org/10.3390/ijerph17041167
N.B. These documents automatically identified may not have been verified by the study sponsor.